18 | 
15 |
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/blog/psi-2025/index.qmd:
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1 | ---
2 | title: openstatsware at the 2025 PSI conference
3 | description: A session titled _Statistical Software Engineering_ and submitted by the working group has been accepted for the 2025 PSI conference.
4 | author: "Alessandro"
5 | date: "2025-02-05"
6 | categories: [news]
7 | image: "psi-banner.png"
8 | ---
9 |
10 | Hi everyone,
11 |
12 | Alessandro here.
13 | A quick blog post to announce that a single-topic session submitted by the working group and titled _Statistical Software Engineering_ has been accepted for the 2025 PSI conference.
14 | The conference will be at Wembley Stadium in London, UK, between June 8^th^ and 11^th^ 2025.
15 |
16 | {fig-align="center"}
17 |
18 | The submission was led by Wilmar Igl (who will be chairing the session as well), and the session will be organised as follows:
19 |
20 | * Wilmar Igl, PhD (ICON) will start the session with the topic "The Mythical Man Month (1975-2025) - Planning, Implementing, and Managing Statistical Software Projects".
21 | The talk will use the 50^th^ anniversary of the classic book entitled "The Mythical Man-month: Essays on Software Engineering" by Brooks (1975) as a starting point to explore modern concepts of software engineering and management, thereby, highlighting established truths and novel insights.
22 | The topic is more general and conceptual in nature, but expected to appeal to a broader audience of statisticians, statistical programmers, and their managers.
23 |
24 | * Pravin Madhavan, PhD (Berry Consultants) will continue with the topic "Continuous Integration (CI) practices for statistical software development", thereby exploring conceptual, yet more technical approaches of software engineering.
25 | In this context, he will also explain related techniques including version control, automated testing, and build automation and give recommendations for best practices based on his experience of building large commercial software solutions, which are also applicable to open-source software.
26 |
27 | * Isaac Gravestock, PhD (Roche) will present the talk "Scaling Statistical Innovation and Open Source Collaborations".
28 | He will explain that novel statistical methods also need user-friendly, robust, high-quality software.
29 | Here, the role of the `openstatsware` working group in particular and the OpenPharma community in general is highlighted as platforms for industry and academic collaborations for development of software leading to the adoption of novel statistical methods.
30 |
31 | * Brian Lang, PhD (MSD) will conclude the session with the topic "Analysis Specification to Execution in R/Shiny".
32 | He will present a practical example of the development of software based on R, Shiny and a database for study analysis planning and execution to accurately and efficiently generate tables, listings, and figures.
33 |
34 | We look forward to seeing you all at the conference (come say hi if you are attending!) and I'd like to personally thank Wilmar and all the presenters for putting together such an exciting session.
35 | I'm sure you'll all enjoy it.
36 |
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/blog/risw2023_session/index.qmd:
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1 | ---
2 | title: "Considerations in developing and using open-source statistical software in Pharma"
3 | author: "Daniel"
4 | subtitle: Summary of our session at this year's Regulatory-Industry Statistics Workshop
5 | description: We shared our working group progress and discussed with the panel and the audience challenges and next steps.
6 | date: "2023-09-29"
7 | categories: [news]
8 | image: "panel_photo.jpeg"
9 | ---
10 |
11 | We were lucky that the `openstatsware` proposed session was accepted in this year's [ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop 2023](https://ww2.amstat.org/meetings/biop/2023/), see the session details [here](https://ww3.aievolution.com/AMSTATevents/index.cfm?do=ev.viewEv&ev=2045). We would like to thank Ya Wang (Gilead, `openstatsware`) who organized the session, and Ning Leng (Genentech) who moderated the session and helped with the invitations. It was great to have Paul Schuette (FDA CDER) as FDA presenter and Ryan Jung (FDA CDER) as additional FDA panelist. The round was completed by Eric Nantz (Eli Lilly) as additional industry panelist.
12 |
13 | Personally, I feel it was awesome to have a nicely filled auditorium of interested workshop participants to present to, despite the late timing of the session in the workshop (Friday afternoon).
14 |
15 | ## Industry presentation
16 |
17 | In the first presentation "First year of the Software Engineering working group - working together across organizations" and on behalf of `openstatsware`, Daniel Sabanes Bove (Roche, `openstatsware`) introduced the working group (WG) and presented its progress during the first year. The slides are available (in slightly modified `html` format for convenience) [here](https://rconsortium.github.io/asa-biop-swe-wg/slides/risw-first-year-wg-sep2023-quarto.html).
18 |
19 | ## FDA presentation
20 |
21 | Paul Schuette gave the second presentation on "Open-source software for regulatory submissions and regulatory environments", which is available on the R Submissions WG website [here](https://github.com/RConsortium/submissions-wg/blob/main/_Documents/OpenSource1c_Paul_S_2023_ASA_biopharma.pdf). Paul started by reminding us of [FDA's clarifying statement on software](https://fda.report/media/109552/Statistical-Software-Clarifying-Statement-PDF.pdf), which was already published in May 2015. After noting that he could only comment on the CDER side of FDA for submissions, he commented on the Study Data Technical Conformance Guide (SDTCG). The SDTCG in particular mandates that all source code for ADaM data sets, as well as TLGs for primary and secondary efficacy analyses need to be submitted. Paul noted that while ASCII files are required and non-ASCII characters are to be avoided, the files could still be with `.r` extension - not only `.txt` files are allowed. Interestingly even `.jl` i.e. Julia files are allowed for module 5 content (although they have not received any Julia submission), while `.sas` and `.r` are allowed for modules 3 to 5. In the future they would like to be able to support more formats.
22 |
23 | ### History of R
24 |
25 | Looking at the history of R, he noted that it followed S which was developed in the same building from Bell Labs as C and Unix, by John Chambers et al. R's major innovation in the 1990s was the CRAN repository. RStudio as a popular IDE is available since 2011. With R Core and the R Foundation, a governance structure is in place. Discussing the various R community based WGs, Paul highlighted the R Submissions WG that already has completed 3 pilot
26 | submissions. Currently, pilot 4 with a container or web assembly based submission is under development. Paul also mentioned Python, which is used in a complementary set of applications such as natural language processing and machine learning, and less in statistics and visualization. He noted that also some commercial software is written in Python. Julia seems to be not (yet?) of great importance in the statistics community.
27 |
28 | ### R for submissions
29 |
30 | Open source software comes with benefits but also challenges. Paul noted the higher pace of changes in the software, and the missing support process when something goes wrong. The need for IT departments supporting the software installations can be another challenge. With almost [20,000 contributed R packages on CRAN](https://cran.r-project.org/web/packages/), it is not trivial to decide which R packages to trust.
31 |
32 | Zooming in on the use of R for submissions, Paul noted that CDER has not received yet a purely R based submission. So far, hybrid submissions combining R and proprietary software have been successfully received. Statistical reviewers also have been using R, in particular for plots that have in some instances already made it into labels. New graduates often come with R knowledge, however best practices are not taught in graduate schools. Paul recommended to reach out to the review divisions early before submissions, and to keep in mind the perspective of the statistical reviewers, who are using laptops for their review work.
33 |
34 | Paul finished with the Stan Lee quote "With great power comes great responsibility", reminding us that we need to use the power of open source software responsibly.
35 |
36 | ## Panel discussion
37 |
38 | 
39 |
40 | ### Popularity of R
41 |
42 | Ning started the panel discussion with asking how popular R is in the companies and FDA. Paul mentioned that they have been seeing an uptick in the recent graduates with R and Python background during the last 5 years. They also encourage staff to be bilingual in the programming languages to increase flexibility. Ryan added that he personally uses R a lot, e.g. to replicate sponsor analyses, and conduct FDA in-house analyses/visualization. Some reviewers use Python but it is only for research purposes not for regulatory purposes. The FDA's Division of Analytics and Informatics (DAI) also has lots of talented R programmers. Eric added that in Eli Lilly they use R more and more, and Daniel added that in Roche Pharma new molecules from this year onwards start their study data analyses in R.
43 |
44 | ### Quality Assessment
45 |
46 | The next question was how the panel members assessed the quality of the packages. Daniel looks always at the source code of the package, which is nowadays typically available on GitHub - are tests included? If there are tests, are they meaningful and sufficiently granular? If yes, are functions documented? Are vignettes available? Eric added that documentation is very important for him to get started with a package, so is a key criterion. A great example here is the [`targets` package](https://books.ropensci.org/targets/) from Will Landau. Paul mentioned that often he does not have a lot of time for the assessment, and provenance is an important factor: do you know where the package came from? Ryan added that not all packages meet the requirements of the reviewers, the issue already arose in one case where a package affiliated with LaTeX was utilized to provide improved fonts in R markdown. The package was rejected in the end because it could not be resolved. He added that well known packages are easier to accept, while not open sourced, proprietary packages would take a lot of time to review and test.
47 |
48 | ### Package Dependencies
49 |
50 | It was great to have a lot of the questions subsequently from the audience. The first was around package dependencies and how to deal with them. Eric mentioned that this was a key issue for the R Submission WG and its pilot submissions to the FDA, where [`renv`](https://rstudio.github.io/renv/articles/renv.html) has been used successfully. A key factor here was to be very verbose in the reviewers guide - you cannot be detailed enough because you want to make sure it can be reproduced on any machine. Also doing the work openly on GitHub helps to be transparent to the reviewers.
51 |
52 | ### Commercial Models
53 |
54 | Another question was whether commercial maintenance of open source packages could be an option, similar as RedHat for Linux. Paul commented that there were different models for monetizing open source software, he is aware of at least three different ones which come with their challenges. Generally, he encourages open source publication of packages and also harmonized cross-company efforts, to avoid surprises in submissions. The open source nature is an opportunity to avoid repeating the company specific macros submissions from sponsors for proprietary software seen in the past.
55 |
56 | ### Containerization
57 |
58 | One question was whether the use of containers could help solve the reproducibility challenge posed from different R and packages installations, and whether this could be integrated into the workflow of statistical reviewers at FDA potentially. Paul commented that there are several pain points. One was e.g. that containers work best with Linux operating systems, while reviewers work on Windows systems. Therefore, IT support was required which adds a level of complexity for the setup. Currently, other solutions are being discussed as part of [Pilot 4 of the R Submissions WG](https://rconsortium.github.io/submissions-wg/pilot4.html). One of them is [`webR`](https://docs.r-wasm.org/webr), where it was important that the security requirements are fulfilled because sessions would be sandboxed in the reviewer's browser session, as Eric added.
59 |
60 | ### Newcomers
61 |
62 | A follow on question to the quality assessment discussion was how newcomers to the biostatistics community could make sure that their packages can be accepted, although they might be unknown in the first place to the community. Daniel started by emphasizing that for him assessing the quality of the packages is not primarily driven by the authors - newcomers could do a great job with using best practices (including methods description in vignettes, tests, documentation, user vignettes, GitHub issues tracking, CRAN publication etc). Paul added that dissemination is important, e.g. Journal of Statistical Software and others are important outlets. Eric added that the [R Weekly site](https://rweekly.org/) and [R Weekly Highlights podcast](https://rweekly.fireside.fm/), which regularly feature new and updated packages released in the R community, is another great way to publicize a new package and increase adoption.
63 |
64 | ### HPC
65 |
66 | The last question was whether extensive computing (e.g. cloud based sponsor submissions) could be handled during an FDA statistical review. Paul mentioned that unfortunately cloud based solutions are not currently compatible with security and other regulatory requirements. However, statistical reviewers have access to an FDA HPC environment, but the access process is not trivial, and can be time intensive.
67 |
68 | 
69 |
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/blog/user-2024/index.qmd:
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1 | ---
2 | title: "openstatsware at UseR!2024"
3 | author: "Daniel, Wilmar, Yann, Friedrich, Joseph"
4 | subtitle: Celebrating the first in-person UseR! event since 2019
5 | description: "The first in-person UseR! conference after the Covid pandemic took place between 8 and 11 July 2024 in Salzburg, Austria."
6 | date: "2024-08-28"
7 | categories: [news, R]
8 | image: "sergio_slide.jpg"
9 | ---
10 |
11 | The first in-person UseR! conference after the Covid pandemic took place between 8 and 11 July 2024 in Salzburg, Austria. Hosted by Roche and the Ludwig-Maximilians-Universität München (Munich) with support by the R Consortium and Linux Foundation, this event brought together about 500 in person attendees as well as virtual participants and presenters. See [here](https://events.linuxfoundation.org/user/) for the conference website which also links to the conference [agenda](https://userconf2024.sched.com/) (includes slides for download, where made available by the presenters) and free [recordings](https://www.youtube.com/c/useRConference_global). See also UseR! talks [assembled by `rOpenSci`](https://ropensci.org/blog/2024/07/19/news-july-2024/).
12 |
13 |
14 | From `openstatsware` attended:
15 |
16 | - Daniel Sabanés Bové (RCONIS)
17 | - Friedrich Pahlke (RCONIS)
18 | - Gregory Chen (MSD)
19 | - Joseph Rickert (R Consortium)
20 | - Lars Andersen (Boehringer Ingelheim)
21 | - Sergio Olmos (Sanofi)
22 | - Will Landau (Lilly)
23 | - Wilmar Igl (ICON)
24 | - Yann Féat (mainanalytics)
25 |
26 | 
27 |
28 | Here a couple of them will state their highlights from the conference and summarize their contribution to the conference.
29 |
30 | Joseph: "The UseR! 2024 conference, which was organized by the R Foundation, Roche, and the Ludwig-Maximilians-Universität München, and financed by the R Consortium was the first in-person event since 2019. It provided a much needed opportunity for R users to establish friendships and meet face-to-face with luminaries from the R world including Kurt Hornik, Uwe Ligges, and Simon Urbanek from the R Core Group and CRAN and Peter Dalgaard,Tomas Kalibera, Martin Mächler, Luke Tierney from the R Core Group, and Hadley Wickham and others from his development team at Posit."
31 |
32 | Wilmar: "I attended my 1st UseR! conference in 2024 to present a personal project to promote civil participation in political decision-making based on R/Shiny technology. The fact that this talk was accepted illustrates the openness of the community and the wide range of potential applications of R and affiliated open-source technologies in society. The conference covered a wide range of other topics in data science and statistics with too many (personal) highlights to mention. The UseR! conference was also special for me because it allowed me to meet many colleagues in real life, whom I have been meeting up with virtually over the last year. Finally, one cannot write about the UseR! conference without mentioning the special vibe of a friendly, inclusive and fun environment, where you can also rub shoulders with long-time champions and rising stars of the R community. UseR! will definitely be on the list of top conferences for the years to come!"
33 |
34 | Yann: "The energy at this conference was incredible. It brought together famous contributors to the R ecosystem and newcomers around topics that are important to me, such as software engineering, statistics, data visualization, reproducibility, etc. This made for interesting and diverse presentations, and more stimulating discussions than one can count. I myself had the opportunity to present the work of the R Validation Hub's [Regulatory R Package Repository](https://github.com/pharmaR/regulatory-r-repo-wg/), and it was a pleasure to exchange ideas on this topic in person. I look forward to future UseR! conferences!"
35 |
36 | Daniel: "I almost can’t believe it, but indeed this was the first UseR! conference I attended. I feel honored to have been part of the organizing and program committee, so I contributed a tiny part to the overall conference organization. It was absolutely amazing to meet so many R community members in person, many of whom I knew by name or video already. Also it was very special to have many R core members mixing with the crowd, giving comments, asking questions, reminding us how R was born in keynote presentations. I really hope that there will be another UseR! conference soon (not just in 5 years) and that I will be able to attend it again. This time, I gave an [`openstatsware` workshop](https://rconis.github.io/user2024-tutorial-gswep/) on good software engineering practice for R packages together with Friedrich, presented the [`{mmrm}` package](https://userconf2024.sched.com/event/1c8uB/mmrm-a-robust-and-comprehensive-r-package-for-implementing-mixed-models-for-repeated-measures-daniel-sabanes-bove-rconis) built by `openstatsware`, and got feedback on the `openstatsguide` by `openstatsware` in the [poster](../../slides/openstatsguide-poster.pdf) session. It was great to bring in so much `openstatsware` to UseR! 2024 😁"
37 |
38 | Friedrich: "Attending the UseR! 2024 conference in Salzburg was a truly enriching experience. This event marked my first in-person UseR! conference, and it exceeded all my expectations. The conference provided an incredible platform for learning and connecting with fellow R enthusiasts. It was especially rewarding to co-lead a 3.5-hour tutorial on 'Good Software Engineering Practice for R Packages' alongside Daniel Sabanés Bové. Our session focused on equipping participants with essential tools and techniques for developing robust and reliable R packages, which was met with great enthusiasm.
39 | In addition to the tutorial, I had the opportunity to present on 'Engineering a Reliable R Package for Regulatory Use Using `{rpact}` as an Example.' This talk gave me the chance to highlight the six-year journey of developing the [`{rpact}` package](https://rpact-com.github.io/rpact/), a tool crucial for confirmatory adaptive clinical trials. I discussed how our validation framework, inspired by GAMP 5 principles, has been instrumental in achieving high levels of automation and reliability, ensuring compliance with stringent regulatory standards.
40 | As a co-founder of [RCONIS](https://rconis.com), our new joint venture that also sponsored the conference, it was an honor to contribute to this fantastic event. Beyond my official roles, I also enjoyed capturing memorable moments as the conference photographer. The entire experience left me eagerly anticipating future UseR! conferences and the continued growth of the R community."
41 |
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/blog/wg_announcement/index.qmd:
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1 | ---
2 | title: "New ASA BIOP working group on Software Engineering"
3 | author: "SWE WG"
4 | subtitle: Fostering open source code collaboration within Biostatistics
5 | description: We are officially announcing the new ASA BIOP scientific working group on Software Engineering (SWE WG).
6 | date: "2022-10-24"
7 | categories: [news, R]
8 | image: "sticker-1200.png"
9 | ---
10 |
11 | With the shift of biostatistics work from proprietary software (e.g. SAS) to R, it is now even more important to write reliable and reproducible code, and to be selective with the R packages we use. This topic is equally relevant for biostatistics work as it is for programming and other roles. A recent [panel discussion](https://www.linkedin.com/pulse/research-software-engineering-clinical-biostatistics-saban%C3%A9s-bov%C3%A9/) on this topic highlighted this evolving need across companies and academia.
12 |
13 | To foster collaboration within biostatistics across organizational silos we proposed a new scientific working group under the umbrella of the [American Statistical Association (ASA) Biopharmaceutical section (BIOP)](https://community.amstat.org/biop/home) which was quickly approved in August this year: The Software Engineering working group (SWE WG). Now we have launched our [landing page](https://community.amstat.org/biop/workinggroups/swe-wg) and [website](https://rconsortium.github.io/asa-biop-swe-wg/) (hosted by the [R Consortium](https://www.r-consortium.org/about) GitHub organization) and want to share this news broadly to raise awareness and attract contributors. We have more than 10 companies and institutions involved in the SWE WG and welcome new members.
14 |
15 | The primary objective of the SWE WG is to engineer R packages that implement important methods that are often utilized in biostatistics but still missing from our R toolbox. The first product is the recently-published R package implementing mixed models for repeated measures (MMRM): [mmrm](https://cran.r-project.org/package=mmrm). In particular, a critical advantage of this package over existing implementations is that it is faster and converges more reliably. It also provides a comprehensive set of features: users can specify a variety of covariance matrices, weight observations, fit models with restricted or standard maximum likelihood inference, perform hypothesis testing with Satterthwaite adjusted degrees of freedom, and extract the least square means estimates by using the [emmeans package](https://github.com/rvlenth/emmeans). We aim to establish the R package [mmrm](https://cran.r-project.org/package=mmrm) as a new standard for fitting MMRM and will communicate it broadly. We welcome any community contributions to the R package, including feedback, questions and feature requests.
16 |
17 | The secondary objective is to develop best practices for engineering high-quality open-source statistical software, and to promote the use of these best practices in the broader biostatistics community via public training materials.
18 |
19 | ➞ Would you like to try out the new package mmrm? Install it from [CRAN](https://cran.r-project.org/package=mmrm) and read the [documentation](https://openpharma.github.io/mmrm/) (hosted by the [openpharma GitHub organization](https://openpharma.github.io/#manifesto)).
20 |
21 | ➞ What do you think is missing in the statisticians' R toolbox? Comment [here](https://rconsortium.github.io/asa-biop-swe-wg/contact_us.html)!
22 |
23 | ➞ Are you developing R packages and are interested in joining the working group? Please visit [our website](https://rconsortium.github.io/asa-biop-swe-wg/) on [how to join](https://rconsortium.github.io/asa-biop-swe-wg/join_us.html) (no ASA membership required).
24 |
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1 |
2 |
20 |
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/contact_us.qmd:
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1 | ---
2 | title: "Contact Us"
3 | ---
4 |
5 | To contact us, please fill out the form below:
6 |
7 |
8 |
9 | Even easier - just login with your GitHub account and leave us a comment in the [discussions page](https://github.com/openstatsware/website/discussions)!
10 |
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/data/members.csv:
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1 | Firstname,Lastname,Affiliation,SWE_WG_Member,MMRM,HTA,bayesian_mmrm,SSD
2 | Alessandro,Gasparini,Red Door Analytics,1,0,0,0,0
3 | Andy,Miskell,Eli Lilly,1,0,0,0,0
4 | Ben,Arancibia,GSK,1,0,0,0,0
5 | Brian,Lang,MSD,1,1,0,0,0
6 | Christian,Stock,Boehringer Ingelheim,1,0,0,1,0
7 | Daniel,Leibovitz,Independent,1,1,0,1,0
8 | Daniel,Sabanés Bové,RCONIS,1,1,0,0,1
9 | Dong,Xi,Gilead Sciences,1,0,0,0,0
10 | Friedrich,Pahlke,RPACT,1,0,0,0,0
11 | Jian,Wang,Eli Lilly,1,0,0,0,0
12 | Keaven,Anderson,Merck,1,0,0,0,0
13 | Kevin,Kunzmann,Boehringer Ingelheim,1,1,0,1,0
14 | Peikun,Wu,R&G US,1,0,0,0,0
15 | Ron,Yu,Gilead Sciences,1,0,0,0,0
16 | Will,Landau,Eli Lilly,1,0,0,1,0
17 | Ya,Wang,Gilead Sciences,1,1,0,0,0
18 | Liming,Li,AstraZeneca,1,1,0,0,0
19 | Julia,Dedic,Roche,0,1,0,0,0
20 | Joe,Rickert,RStudio & R Consortium,1,0,0,0,0
21 | Michelle,Zhang,Affamed,1,0,0,0,0
22 | Jack,Talboys,Novartis,1,0,0,0,0
23 | Andrew,Bean,Novartis,1,0,0,1,0
24 | Terri,Johnson,Edwards Lifesciences,1,0,0,0,0
25 | Yoni,Sidi,Sanofi,1,1,0,1,0
26 | Vitaly,Druker,AstraZeneca,1,0,0,0,0
27 | Juliane,Manitz,EMD Serono,1,0,0,0,0
28 | Pascal,Kieslich,Merck KGaA,1,0,0,0,0
29 | Songgu,Xie,Regeneron,1,0,0,0,0
30 | Ryan,Wang,Johnson & Johnson,1,0,0,0,0
31 | Gregory,Chen,MSD,1,0,1,0,0
32 | Laura,Harris,Denali,1,0,0,0,0
33 | Colombe,Chappey,Pfizer,1,0,0,0,0
34 | Martin,Kappler,Cytel,1,0,0,0,0
35 | Pravin,Madhavan,Berry Consultants,1,0,0,0,0
36 | Nick,Berry,Berry Consultants,1,0,0,0,0
37 | Quang,Nguyen,Regeneron,1,0,0,0,0
38 | Wilmar,Igl,ICON,1,0,0,0,0
39 | Clara,Beck,Bayer,1,0,0,0,0
40 | Issac,Gravestock,Roche,0,0,1,0,0
41 | Christos,Kokaliaris,Roche,0,0,1,0,0
42 | Michael,Seo,Roche,0,0,1,0,0
43 | Miranta,Antoniou,Roche,0,0,1,0,0
44 | Rossella,Belleli,Roche,0,0,1,0,0
45 | Cedric,Revil,MSD,0,0,1,0,0
46 | Chrysostomos,Kalyvas,MSD,0,0,1,0,0
47 | Henrik,Thomsen,Novo Nordisk,1,0,0,0,0
48 | Yann,Féat,mainanalytics,1,0,0,0,0
49 | Sergio,Olmos,Sanofi,1,0,0,0,0
50 | Fan,Wu,Sanofi,1,0,0,0,0
51 | Peng,Zhang,CIMS Global,1,0,0,0,0
52 | Elias Laurin,Meyer,Berry Consultants,1,0,0,0,0
53 | Michał,Majka,Erste Group,1,0,0,0,0
54 | Lorin,Towle-Miller,GSK,1,0,0,0,0
55 | Nils,Penard,UCB,1,0,0,0,0
56 | Marianne,Grinberg,UCB,1,0,0,0,0
57 | Kristian,Brock,AstraZeneca,1,0,0,0,1
58 | Jeffrey,Long,GSK,1,0,0,0,0
59 | Serene,Jiang,Johnson & Johnson,1,0,0,0,0
60 | Lars,Andersen,RPACT,1,0,0,0,0
61 | Christian Haargaard,Olsen,Novo Nordisk,0,0,1,0,0
62 | Simon,Clancy,Novo Nordisk,0,0,1,0,0
63 | Thomas,Maltesen,Novo Nordisk,0,0,1,0,0
64 | Matthew,Phelps,Novo Nordisk,0,0,1,0,0
65 | Nicolai Skov,Johnsen,Novo Nordisk,0,0,1,0,0
66 | Keovilay,Chanthavinout,Roche,0,0,1,0,0
67 | Rajesh,Hagalwadi,MaxisIT,1,0,0,0,0
68 | Kamil,Sijko,Transition Technologies Science,1,0,0,0,0
69 | Claudia,Carlucci,Daiichi Sankyo,1,0,1,0,0
70 | Sergei,Krivtov,Daiichi Sankyo,1,0,1,0,0
71 | Isaac,Gravestock,Roche,1,0,1,0,0
72 | Adam,Omidpanah,BMS,1,0,0,0,0
73 | Audrey,Yeo,Independent,1,0,0,0,0
74 | Natalie,Dennis,Daiichi Sankyo,0,0,0,0,0
75 | Tao,Jiang,Genentech,1,0,0,0,0
76 |
--------------------------------------------------------------------------------
/data/news.csv:
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1 | Date,Text
2 | 02/05/2025,We are proud to announce that our single-topic session titled Statistical Software Engineering has been accepted for the 2025 PSI conference
3 | 11/14/2024,The HTA-R Pharma workstream is proud to announce `maicplus` v0.1 has been published on CRAN
4 | 09/16/2024,`openstatsguide` is published
5 | 08/28/2024,`openstatsware` at UseR!2024
6 | 04/21/2024,New European working group co-chair
7 | 04/08/2024,First Julia package from `openstatsware` published
8 | 03/12/2024,We are now also an EFSPI and PSI Special Interest Group!
9 | 03/05/2024,Announcing the Clinical Trials Task View Hexwall
10 | 10/18/2023,Celebrating 5 workshops on good SWE practices in 2023
11 | 10/03/2023,Summary of our session at this year's Regulatory-Industry Statistics Workshop
12 | 9/27/2023,Announcing the new short name and logo
13 | 7/25/2023,R Package Workshop in Rockville (MD) on 26th September open for registration
14 | 7/20/2023,{brms.mmrm} R package made public as open-source software (under development).
15 | 4/27/2023,Bayesian MMRM workstream page launched
16 | 3/9/2023,Online workshop in Asia on 24th March open for registration
17 | 3/5/2023,HTA Workstream is here now
18 | 2/13/2023,Workshop on good software engineering practice for R
19 | 1/20/2023,Presentations are now available on this site
20 | 11/16/2022,Article introducing the SWE WG in BIOP Report
21 | 10/24/2022,Announcing the new ASA BIOP working group on Software Engineering
22 | 10/7/2022,Initial publication of the website.
23 | 10/10/2022,Added hex sticker for the working group. Credits to Kalashnyk on Flaticon for creating the sticker icon.
24 |
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/goals.qmd:
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1 | ---
2 | title: "Goals"
3 | ---
4 |
5 | openstatsware is a [scientific working group](https://community.amstat.org/biop/workinggroups/swe-wg) of the [American Statistical Association (ASA) Biopharmaceutical section (BIOP)](https://community.amstat.org/biop/home) and a [European Special Interest Group (SIG)](https://www.psiweb.org/sigs-special-interest-groups/software-engineering) sponsored by [Statisticians in the Pharmaceutical Industry (PSI)](https://www.psiweb.org/about-us) and the [European Federation of Statisticians in the Pharmaceutical Industry (EFSPI)](https://efspi.org/).
6 |
7 | Our goals are to:
8 |
9 | - **Engineer selected R-packages** to fill in gaps in the open-source statistical software landscape, and to promote software tools designed by the working group through publications, conference presentations, workshops, and training courses.
10 |
11 | - **Develop good SWE practices** for engineering high-quality statistical software and promote their use in the broader Biostatistics community via public training materials.
12 |
13 | - **Communicate and collaborate** with other R software initiatives including via the [R Consortium](https://www.r-consortium.org/).
14 |
15 | ```{=html}
16 |
18 |
15 | 20 | Welcome to the home page of the openstatsware working group. We are a scientific working group in the American Statistical Association (ASA) Biopharmaceutical Section (BIOP), as well as a European Special Interest Group (SIG) sponsored by Statisticians in the Pharmaceutical Industry (PSI) and the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI). 21 |
22 |23 | To learn more about the working group see the about us page. We thank all our sponsors for their generous support. 24 |
25 |Latest news:
33 |{news_data$Date[i]}: {news_data$Text[i]}
") 22 | print(txt) 23 | } 24 | } 25 | -------------------------------------------------------------------------------- /videos.qmd: -------------------------------------------------------------------------------- 1 | --- 2 | title: "Videos" 3 | --- 4 | 5 | To be added later. 6 | -------------------------------------------------------------------------------- /webinars.qmd: -------------------------------------------------------------------------------- 1 | --- 2 | title: "Webinars" 3 | --- 4 | 5 | To be added later. 6 | --------------------------------------------------------------------------------