Senior Biostatistics Lead for Clinical Development

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

Benefits offered by this job

Hybrid schedule

Equity / stock options

Discretionary bonus

Job summary

Beeline Medicines seeks an Associate Director, Biostatistics to provide statistical leadership across clinical programs, shaping design, sample size, and analysis strategies through development and regulatory submissions.

You will lead cross-functional study teams, coordinate SAPs, and ensure timely, high-quality deliverables for internal and CRO partners while communicating complex statistics to clinical and executive audiences.

Qualifications

• PhD in Biostatistics or related quantitative discipline required.
• 5+ years biostatistics experience in pharma/biotech/CRO settings preferred.
• Experience in immunology, inflammation, or related therapeutic area preferred.
• Advanced proficiency in SAS and/or R for analysis and programming.
• Strong knowledge of clinical trial design, ICH E9 principles, and CDISC ADaM.

Responsibilities

• Lead statistical design and analysis plans for one or more clinical studies.
• Oversee SAPs, sample size calculations, and randomization strategies.
• Oversee production of tables, listings, and figures (TLFs) with internal or CRO teams.
• Collaborate with Clinical, Regulatory, and Data Management on study design and data review.
• Contribute statistical input to regulatory submissions and health authority responses.
• Review clinical study reports and publications for statistical accuracy.
• Ensure deliverables comply with ICH guidelines and regulatory standards.

Skills

Biostatistics

Statistical leadership

Communication to non-statisticians

SAS

R

Education

PhD in Biostatistics or related field

Tools

SAS

R

Job description

Beeline Medicines seeks an Associate Director, Biostatistics to provide statistical leadership across clinical programs, shaping design, sample size, and analysis strategies through development and regulatory submissions.

You will lead cross-functional study teams, coordinate SAPs, and ensure timely, high-quality deliverables for internal and CRO partners while communicating complex statistics to clinical and executive audiences.