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Powering the Future of Genetic Medicines
Senior Manager, Statistical Programming
Location
United States
Posted
118 days ago
Salary
$154K - $179K / year
Seniority
Senior
Job Description
Senior Manager, Statistical Programming
4D Molecular Therapeutics
• Provide technical leadership for statistical programming activities for a given clinical development program. • Accountable for the accuracy, quality, and timeliness of programming deliverables for clinical trial reporting, integrated safety/efficacy analyses, and global regulatory submissions. • Drive the development and maintenance of programming standards and tools, ensuring compliance with CDISC standards, ICH GCP, and applicable regulatory requirements. • Collaborate closely with cross‑functional teams and external vendors.
Job Requirements
- Master’s or PhD in Statistics, Biostatistics, Mathematics, Computer Science, or related field (BS with significant experience considered).
- 7+ years of statistical programming experience in pharmaceutical, biotechnology industry w/ Bachelors. 4+ years w/ Masters. 3+ years w/ PhD
- Expert proficiency in SAS (Base, Macro, Stat, Graph, ODS); working knowledge of R or Python preferred.
- Deep knowledge of CDISC SDTM/ADaM standards, metadata, and regulatory submission requirements.
- Experience with Pinnacle 21 and preparation of reviewer’s guides.
- Strong understanding of clinical trial design, data collection, and reporting processes.
- Experience in Gene Therapy
- Experience in ophthalmology preferred
- Excellent communication, problem‑solving, and project management skills.
- Ability to manage multiple priorities in a fast‑paced, matrixed environment.
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