Associate Director, Biostatistics

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category‑leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best‑in‑class and first‑in‑disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life‑changing impact.

Led by an established executive team and backed by world‑class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune‑mediated diseases can live life fully.

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.

This role requires both deep statistical expertise and the ability to communicate complex quantitative concepts clearly to clinical, regulatory and executive audiences.

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on‑site per week – currently designated as Tuesday and Wednesday. Additional on‑site days may be required based on business needs, team priorities or leadership direction.

• 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 QC 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
• Education:
  
  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 as applicable.
• Experience with CRO statistical oversight and governance – including statistical deliverable review, CRO quality management and the establishment of biostatistics standards within a virtual or outsourced development model.
• 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…