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Urgent! Senior Statistical R Programmer Job Opening In San Francisco California – Now Hiring Katalyst Healthcares & Life Sciences

Senior Statistical R Programmer



Job description

Job Description:


  • The candidate will have the opportunity to help shape data and programming infrastructure, drive the adoption of R in a regulated environment, gain an in-depth understanding of drug development in a fast-moving industry environment and subject domain knowledge in neurodegeneration.

  • The ideal candidate will have extensive experience supporting drug development and clinical study projects; will have excellent statistical programming and problem-solving skills; and will be able to function as a leader and individual contributor.

  • The candidate will take the initiative to stay current on technologies and methods, will champion the use of open-source software for clinical trial reporting, come up with innovative solutions to challenging problems, and work with Biometrics management to help set the overall strategic direction of the group.


Responsibilities:


  • Lead statistical programming deliverables including: generation of data visualizations or summary reports to support internal decision making and regulatory interactions (IND/CTA filings, annual safety reporting, etc.); providing input for statistical analysis plans, study protocols and clinical study reports; reviewing study randomization specifications; collaborating with Clinical Data Management on case report form design, data review plans, and external data transfer specifications; collaboration with the study team to review data and manage timelines; oversight of Biometrics CRO deliverables.

  • Design, develop, and validate CDISC analysis data (i.e., SDTM, ADaM) for use with statistical reporting code and analytics applications.

  • Develop and manage reusable code for interactive data visualization, exploratory analysis, and statistical summaries in clinical study reports.

  • Work with the Biometrics Team to establish innovative processes to ensure high data quality, reporting of analysis results, and analysis reproducibility.

  • Support the Biometrics Team in efforts to build, maintain, and continuously improve an R infrastructure that is suitable for regulatory submission work.


Requirements:


  • At minimum, a bachelor's degree in Statistics, Biostatistics, Data Science, Mathematics, or a related field is required.

  • At least five years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies.

  • Demonstrated ability to effectively lead projects and collaborate cross-functionally.

  • Exceptional R programming skills (including tidy verse, Markdown, Shiny, HTML widgets, development of R packages, working with IT staff to build R infrastructure), experience applying software development concepts, well versed in reproducible research methods, and proficiency in using code repositories like Git/GitHub (or similar tools) for collaboration and versioning of operational, robust, and well documented code.

  • Able to work in a Linux/Unix environment (including shell scripting).

  • Applied experience with SDTM or ADaM CDISC data.

  • Demonstrated experience in creating compelling data visualizations to help teams make correct data driven decisions and effectively communicating results to team members.

  • Able to demonstrate a solid understanding of statistical principles and methods used in clinical study reports or scientific publication analyses.



Required Skill Profession

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