Senior Biostatistics Lead - Immunology & Trials (Hybrid)

Beeline Medicines; Boston (MA); Hybrid; USD 181,000 - 235,000; Full time

Benefits offered by this job

Hybrid schedule

Annual bonus

Equity

Job summary

Beeline Medicines, a clinical‑stage biotechnology company, seeks an Associate Director of Biostatistics to lead statistical strategy across development programs and oversee CRO partners, ensuring high-quality outputs for regulatory submissions. The role requires clear communication of complex quantitative results to clinical, regulatory, and executive audiences.

The position combines scientific rigor with leadership in a hybrid work environment, with on-site collaboration two days per week and

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.

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 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

Skills

Biostatistics expertise

Statistical leadership

Regulatory submissions

Education

PhD in Biostatistics or related field

Tools

SAS

R

Job description

Beeline Medicines, a clinical‑stage biotechnology company, seeks an Associate Director of Biostatistics to lead statistical strategy across development programs and oversee CRO partners, ensuring high-quality outputs for regulatory submissions. The role requires clear communication of complex quantitative results to clinical, regulatory, and executive audiences.

The position combines scientific rigor with leadership in a hybrid work environment, with on-site collaboration two days per week and