Remote Senior Statistical Programmer / Analyst

Role: Senior Statistical Programmer Consultant supporting clinical trial data processing and analysis within a Biometrics Department, ensuring compliance with SOPs, GCP, 21 CFR, and ICH guidelines.

Responsibilities:

• Program, validate, and process derived datasets, tables, figures, and listings from clinical trial data, including external sources.
• Perform ad hoc analyses for publications and support R&D functions.
• Oversee programming deliverables from CROs and contribute to design/review of key documentation such as SDTM/ADaM specs and Statistical Analysis Plans.
• Develop and validate CDISC-compliant data for electronic submissions and support submission documentation.
• Manage project timelines, ensure high-quality deliverables, and assist in coordinating internal and external programming resources.
• Participate in creating departmental guidelines, macros, and utilities to improve processes.

Qualifications & Skills:

• Bachelor’s or Master’s degree in Computer Science, Mathematics, Engineering, Medical, or related fields.
• 5+ years (BS) or 3+ years (MS) experience in SAS and R programming within the pharmaceutical industry.
• Strong SAS, SAS Macro, and R programming skills, with knowledge of industry standards and clinical trial data processes.
• Experience with data integrations (ISS/ISE) and electronic submission standards.
• Excellent communication skills to convey technical details effectively.