Associate Director, Biostatistics
Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering precision therapies for autoimmune and inflammatory diseases. The company’s portfolio includes potential best‑in‑class and first‑in‑disease therapeutic candidates that target key pathways governing dysregulated immunological and inflammatory responses.
Job Summary
The Associate Director, Biostatistics provides statistical leadership for assigned clinical development programs, including study design, analysis planning, and statistical reporting in support of clinical trial execution and regulatory submissions. Serves as the lead statistician on cross‑functional study teams, shaping protocol design, sample size and power considerations, and analysis strategy from early development through submission. Oversees the quality and timeliness of statistical deliverables, whether produced internally or through CRO partners, and ensures all outputs meet ICH and regulatory expectations.
Responsibilities
- Serve as lead statistician for one or more clinical studies, from protocol design through clinical study report.
- Develop statistical analysis plans (SAPs), sample size/power calculations, and randomization schemes.
- Oversee production and quality control of tables, listings, and figures (TLFs) performed internally or by CROs.
- Collaborate with Clinical, Regulatory, and Data Management on study design, protocol development, and data review.
- Contribute statistical input to regulatory submissions, briefing documents, and health authority responses.
- Review and provide statistical input on clinical study reports and publications.
- Ensure statistical deliverables comply with ICH guidelines and applicable regulatory standards.
- Perform other duties and responsibilities as assigned.
Qualifications
- PhD in Biostatistics, Statistics, or a closely related quantitative discipline (required).
- 5+ years of biostatistics experience in pharmaceutical, biotechnology, and/or CRO settings (preferred).
- Experience in immunology, inflammation, or a related therapeutic area (preferred).
- Advanced proficiency in SAS and/or R for statistical analysis and programming.
- Strong knowledge of clinical trial design and operation, ICH E9 principles, and CDISC ADaM standards.
- Experience with adaptive trial designs, interim analyses, and Bayesian or frequentist methods.
- Experience with CRO statistical oversight and governance, including deliverable review and quality management.
- Ability to lead statistical strategy discussions with cross‑functional and external stakeholders.
- Sound scientific judgment in interpreting and communicating complex statistical results.
- Ability to translate statistical concepts for non‑statistician audiences, including regulatory agencies.
- Effective presentation skills for program teams and senior leadership.
- Skilled at collaborating cross‑functionally with Clinical, Regulatory, and Data Management colleagues.
Pay
Salary range: $181,000 – $235,000 USD (varies by location and determined based on experience, qualifications, and local law). A discretionary annual bonus and long‑term incentive award (e.g., equity) may be available based on individual and company performance.
Schedule
Hybrid work arrangement: minimum of two on‑site days per week (currently Tuesday and Wednesday). Additional on‑site days may be required based on business needs, team priorities, or leadership direction.
Benefits
- Comprehensive benefits package tailored to the country and region, in compliance with local laws.
- Competitive health and wellness coverage (structure and premiums vary by country).
- Paid time off, public holidays, and additional leave entitlements in accordance with local requirements.
- Flexible work arrangements / hybrid schedule.