Senior Statistical Programmer

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

📋 Description

• Assist in the analysis and reporting of intricate clinical data from clinical trials, real-world evidence (RWE), and observational studies related to medical devices.

• Create tables, listings, and figures (TLFs) that summarize the findings of studies.

• Collaborate with the clinical data scientist in developing the statistical analysis plan (SAP) and suggest analytical methodologies.

• Independently establish, develop, and validate TLF specifications and shells.

• Draft, maintain, and review SAS programs primarily for generating analysis datasets and TLFs.

• Run programs while troubleshooting and resolving programming and data-related issues.

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

• Oversee the quality control and validation of programmed outputs, which includes independent/double programming.

• Evaluate the work of other programmers.

• Analyze output results and pinpoint those that require additional statistical focus.

• Ensure traceability, reproducibility, and compliance with CDISC data standards, including SDTM and ADaM.

• Enhance and maintain 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 deliverables for reporting and submissions.

• Aid in additional analysis or clinical data science tasks as assigned.

⛳️ Requirements

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

• A minimum of 5 years of experience in statistical programming within clinical research.

• Advanced skills in statistical programming (SAS or R; SAS preferred), particularly in developing complex analysis datasets and TLFs.

• Familiarity with clinical data standards (CDISC, including SDTM and ADaM).

• Proficient understanding of statistical methods employed in clinical trials.

• Strong grasp of TLF structure and clinical study data.

• Capability to work autonomously and manage several deliverables and deadlines within a cross-functional team.

• Exceptional attention to detail and a quality-control mindset, including reviewing colleagues' work.

• Effective written and verbal communication skills.

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

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

• Background in medical device or pharmaceutical clinical trials.

• Familiarity with data visualization tools (Tableau, Spotfire, R Shiny, Python Dash).

🏝️ Benefits

• Health insurance.

• Dental insurance.

• Vision insurance.

• Life insurance.

• Short-term disability insurance.

• Long-term disability insurance.

• 401(k).

• Paid time off.

• Comprehensive benefits package for full-time employees.

• Equal opportunity employer that values diversity.