Principal Statistical Programmer, R Programming

About the role

The Statistical Programmer is a key contributor to the research team, playing a crucial role in analyzing and interpreting complex data sets. They are responsible for developing and implementing statistical methodologies that will enhance our study outcomes. Reporting to the team manager, the programmer must ensure data integrity and accuracy in every phase of the project. With proficiency in various programming languages and statistical tools, they collaborate closely with team members to streamline data processes and deliver insights that drive decision-making.

Responsibilities

• Develop, update or validate R packages for clinical trial analysis (SDTM, ADaM, tables, figures, listings, submission packages, data review, etc.).
• Building complex R-Shiny applications (animations, dashboards) to address clinical questions, Health Authority requirements, and decision-making.
• Generate submission ready statistical outputs using R-Markdown or similar tools.
• Lead implementation in R and train other team members.
• Write or review specifications and documentation for applications.
• Collaborate with clinical, statistical and data management stakeholders to understand their requirements.
• Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group.
• Conduct statistical programming work of clinical data using R.
• Create and/or validate all safety and efficacy study output requirements (e.g. ADaM, TLFs) consistent with data definitions and specifications and relevant study documentation (e.g. protocol, SAP, aCRF).
• Collaborates with peers and statisticians to ensure the quality, accuracy and submission readiness of clinical data.

Qualifications

• Strong experience in R programming and package/application development, particularly for clinical trial data including developing and validating R packages from CRO or Pharmaceutical Industry.
• Strong programming skills in R, R Shiny and R Markdown.
• Proven experience in applying R and R-Shiny for the analysis and reporting of clinical trials.
• Strong skills in data visualization and data wrangling using R.
• Proficiency in using R packages for data exploration and visualization.
• Application of statistical methodology and concepts in clinical trial analysis.
• Experience with R-Shiny apps for data exploration.
• Advanced knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs.
• Ability to conduct statistical programming of clinical data using R and create/validate safety and efficacy outputs (ADaM, TLFs) aligned with study documentation (protocol, SAP, aCRF).
• Exposure to clinical trial and drug development studies is highly desirable though not absolutely required for an exceptional candidate.

Pay

The potential base pay range for this role, when annualized, is $98,200.00 - $273,200.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.