Manager, Statistical Programming

This is a fully remote position, open to applicants in United States.

📋 Description

• Strategize and execute statistical programming for designated studies that support clinical trials, regulatory submissions, publications, and on-demand analysis requests.

• Monitor programming schedules and highlight potential risks to the Director.

• Create or supervise CDISC-compliant SDTM and ADaM datasets, conducting conformance checks using tools like Pinnacle 21.

• Develop and validate TLFs and analysis datasets utilizing SAS and R.

• Conduct independent quality control of programming produced by others, including cross-language validation when appropriate.

• Delegate and review the work of internal and CRO programmers; offer guidance, feedback, and mentorship.

• Assess CRO deliverables, specifications, and documentation for quality and compliance with standards.

• Engage in study meetings alongside Clinical Operations, Data Management, Safety, and Biostatistics teams.

• Write and maintain batch scripts to schedule SAS and R jobs and distribute reports.

• Prepare programming documentation for electronic submissions, including define.xml inputs and reviewer guide materials.

• Contribute to the development of SAS macros, R functions, standards, templates, SOPs, and cross-functional projects.

• Provide insights on programming tools and infrastructure requirements, collaborating with IT as necessary.

⛳️ Requirements

• BS/BA in Statistics, Computer Science, Mathematics, Life Sciences, or a related discipline; MS degree preferred.

• Over 8 years of statistical programming experience in the pharmaceutical, biotech, or CRO sectors with a BS, or more than 6 years with an MS.

• 1–2 years of experience in supervising programmers or acting as the lead programmer on a study.

• Proficient in SAS (Base, Macro, SQL, STAT, ODS/Graph).

• Working knowledge of R for clinical data manipulation, analysis, and reporting (e.g., tidyverse, admiral, gt, rtables, or similar).

• Experience in developing R Shiny applications for interactive data review, safety monitoring, or visualization of clinical trial data is an advantage.

• Familiarity with CDISC SDTM and ADaM, controlled terminology, and Define-XML.

• Understanding of ICH guidelines and GCP; experience with regulatory submissions is an advantage.

• Experience with Python for automation, data processing, or tooling is a plus.

• Excellent written and verbal communication skills; comfortable collaborating directly with statisticians and clinical teams.

🏝️ Benefits

• Annual performance bonus

• Health Insurance (Medical / Dental / Vision)

• Disability, Life & Long-Term Care Insurance

• Holiday Pay

• Tracking Free Vacation Program

• 401(k) Plan Match

• Educational Assistance Benefit

• Fitness Center Reimbursement