Sr. Manager, Statistical Programming
Sr. Manager, Statistical Programming
SF Bay Area (Fully Remote option available)
Compensation: $160,000-180,000 + Bonus + Equity
An expanding biotech company developing long-acting therapies for rare endocrine and oncology indications is looking to add a stat programming leader to their team. Their proprietary sustained-release platform enables precise, controlled delivery of active molecules-resulting in improved safety, efficacy, and patient convenience. With two approved therapies and a robust pipeline spanning growth hormone deficiency, hypoparathyroidism, achondroplasia, and solid tumors, the company has scaled rapidly, growing revenue from under $10M to nearly $400M in five years! The team is led by seasoned executives with deep expertise in drug development and regulatory strategy. If you are looking for an opportunity to join a company with a proven track-record of getting therapies approved with a scalable platform providing tremendous upside don't hesitate to apply.
Primary Responsibilities
- Lead statistical programming activities across clinical trials from initiation through submission.
- Represent programming in cross-functional study teams, contributing to planning and execution.
- Develop and validate SDTM and ADaM datasets in accordance with CDISC standards.
- Generate and QC tables, listings, and figures (TLFs) for study reports and regulatory filings.
- Support biostatisticians with planned and exploratory analyses.
- Build and maintain reusable macros, templates, and tools to enhance programming efficiency.
- Collaborate with Biostatistics, Data Management, and Medical Writing to ensure high-quality deliverables.
- Ensure programming outputs meet timelines and quality standards, aligned with SOPs and industry best practices.
Ideal Qualifications
- Bachelor's degree in a quantitative field with 8+ years of experience, or Master's degree with 5+ years.
- Proven experience leading programming for clinical trials and technical projects.
- Strong knowledge of CDISC standards (SDTM, ADaM).
- Solid understanding of clinical development and regulatory submission processes.
- Advanced SAS programming skills, including macro development.
- Familiarity with additional tools/languages (e.g., R, Python, Git) is a plus.
- Experience contributing to departmental tools and automation preferred.
- Strong communication and collaboration skills.
- Detail-oriented and adaptable to shifting priorities.
- Oncology or Endocrinology experience helpful but not required
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