Position Overview
We are seeking a skilled Senior Programmer, Data Standards & Statistical Programming to support statistical programming activities for clinical trials. This role involves working closely with cross-functional teams to develop and validate clinical data outputs using SAS. The ideal candidate will have experience with CDISC standards and regulatory submissions, and will play a key role in ensuring high-quality data deliverables.

Key Responsibilities

• Perform statistical programming activities for assigned clinical trials in a collaborative team setting.
• Develop and validate SDTM and ADaM datasets using SAS.
• Create and maintain SAS macros to ensure consistency and accuracy in data outputs.
• Generate clinical data summaries, tables, listings, and graphs based on study requirements and timelines.
• Ensure compliance with CDISC standards and internal workflows for data deliverables.
• Conduct statistical analysis to support clinical trial results interpretation.
• Produce SDTM and ADaM datasets, SAS transport files, Define.xml, Pinnacle 21 reports, and reviewer guides for regulatory submissions.
• Work closely with biostatistics, data management, and programming teams to optimize processes and meet study goals.
• Review statistical analysis plans, data specifications, TLF shells, and trial documentation.
• Identify data inconsistencies and collaborate with team members to resolve them.
• Support the preparation of integrated datasets and outputs for regulatory filings.

Qualifications

• Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, or a related field.
• Minimum of 8+ years of statistical programming experience in the biopharma industry, including Phase I–III clinical trials.
• At least 5 years of experience working with CDISC SDTM and ADaM standards.
• Experience with oncology clinical trials, including RECIST-based endpoint analysis, is preferred.
• Strong background in SAS programming (SAS Base, SAS Macros, SAS/Graph, SAS/STAT) and statistical analysis.
• Experience developing datasets and outputs for NDA submissions.
• At least 2 years of experience in a fast-paced biotech environment.
• Knowledge of R and/or Python is a plus.
• Strong communication skills and ability to work effectively in a cross-functional team environment.