Senior Statistical Programmer

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

📋 Description

• Participate in the creation of the statistical analysis plan (SAP), suggesting analytical strategies in partnership with the clinical data scientist.

• Independently establish, develop, and validate specifications and shells for tables, listings, and figures (TLF).

• Write, maintain, and review primarily SAS programs to produce analysis datasets and TLFs, including complex or unique outputs.

• Execute programs while independently diagnosing and resolving programming and data-related issues.

• Integrate TLF outputs into clinical study reports (CSRs) and other related deliverables.

• Oversee quality control and validation of programmed outputs, including independent/double programming and reviewing the work of fellow programmers.

• Analyze outputs and pinpoint results that require additional statistical scrutiny.

• Ensure traceability, reproducibility, and compliance with relevant data standards, such as CDISC, SDTM, and ADaM.

• Maintain and enhance programming standards, documentation, reusable code, and macros.

• Collaborate with Data Management teams regarding dataset structure and specifications.

• Support Regulatory Affairs and Quality Assurance teams with programming tasks for reporting and submissions.

• Assist with additional analyses or clinical data science responsibilities as needed.

⛳️ Requirements

• Bachelor's or Master's degree in a relevant technical discipline (e.g., statistics, computer science, mathematics, data science, or epidemiology).

• At least 5 years of experience in statistical programming within clinical research.

• Advanced proficiency in statistical programming (SAS or R; SAS is preferred), including complex analysis datasets and TLFs.

• Knowledge of clinical data standards (CDISC, including SDTM and ADaM).

• Working familiarity with statistical methods applied in clinical trials.

• Strong comprehension of TLF structure and clinical study data.

• Capacity to work autonomously and manage multiple deliverables and deadlines within a cross-functional team.

• Keen attention to detail and a quality-control focus, including reviewing the work of others.

• Effective written and oral communication skills.

• Experience in producing TLFs for clinical study reports or regulatory submissions.

• Familiarity with regulatory guidelines and standards (FDA and Global; e.g., ISO 14155, ICH).

• Experience in clinical trials involving medical devices or pharmaceuticals.

• Knowledge of data visualization tools (Tableau, Spotfire, R Shiny, Python Dash).

🏝️ Benefits

• Health, dental, and vision insurance.

• Life insurance.

• Short-term and long-term disability insurance.

• 401(k).

• Paid time off.