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