Associate Director, Biostatistics

The role

The Associate Director, Biostatistics provides statistical leadership for clinical development programs. This person will lead study design, analysis planning, and statistical reporting for clinical trials and regulatory submissions.

What you will do

• 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

Required qualifications

• PhD in Biostatistics, Statistics, or a closely related quantitative discipline required.
• 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.
• 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 at presenting statistical findings to program teams and senior leadership.
• Skilled at collaborating cross-functionally with Clinical, Regulatory, and Data Management colleagues.

Nice to have

• 5 years of biostatistics experience in pharmaceutical, biotechnology, and/or CRO settings
• Experience in immunology, inflammation, or a related therapeutic area

Benefits

• Competitive health and wellness coverage
• Paid time off, public holidays, and additional leave entitlements
• Flexible work arrangements / hybrid schedule

About the company

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.