Senior Statistical Programmer/Analyst Consultant – TA, Gene Therapy

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

📋 Description

• Oversee statistical programming tasks for Gene Therapy clinical trials from the initiation phase through to database lock, analysis, and reporting.

• Create, review, and validate SAS programs for SDTM, ADaM, Tables, Listings, and Figures (TLFs).

• Work in collaboration with Biostatisticians to interpret study protocols, Statistical Analysis Plans (SAPs), and programming specifications.

• Generate and validate clinical datasets along with statistical outputs for safety and efficacy evaluations.

• Assist in interim and final analyses, database lock procedures, and the preparation of Clinical Study Reports.

• Ensure that programming deliverables meet CDISC standards and adhere to relevant regulatory requirements.

• Conduct independent validation and quality control of datasets, TLFs, and other programming outputs.

• Support regulatory submissions and respond to programming-related inquiries from both internal and external stakeholders.

• Manage timelines, deliverables, and quality expectations at the study level.

• Identify and resolve intricate programming challenges while proactively communicating potential risks.

• Offer technical guidance and mentorship to fellow Statistical Programmers.

• Engage in client-facing meetings and collaborate with cross-functional project teams.

⛳️ Requirements

• Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related discipline.

• Extensive experience in statistical programming for clinical trials within a pharmaceutical, biotechnology, or CRO setting.

• Direct experience in supporting Gene Therapy clinical trials is mandatory.

• Strong proficiency in SAS programming is essential.

• In-depth knowledge of CDISC standards, including SDTM and ADaM.

• Experience in developing and validating clinical trial TLFs.

• Capability to independently lead study-level programming tasks.

• Comprehension of clinical trial processes, statistical analyses, and regulatory reporting.

• Exceptional analytical, communication, and problem-solving abilities.

🏝️ Benefits

• Opportunities for professional development and training.

• A supportive workplace culture.

• Close management and training support.

• Ongoing training programs.

• Commitment to equal opportunity and diversity/inclusivity.