Senior Biostatistics Lead for Clinical Trials & Submissions

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

Job summary

Beeline Medicines in the United States seeks an Associate Director, Biostatistics to provide statistical leadership across clinical development programs, shaping design, analysis plans, and regulatory submissions. You will oversee study design, sample size and analysis strategy from early development through submission.

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

Qualifications

• PhD in Biostatistics or closely related field required.
• Minimum of 5 years biostatistics experience in pharma/biotech/CRO settings preferred.
• Experience with immunology/inflammation or related areas is a plus.

Responsibilities

• Serve as lead statistician for one or more clinical studies from protocol design to study report.
• Develop SAPs, and perform sample size/power calculations and randomization schemes.
• Oversee production and QC of tables, listings, and figures (TLFs) by internal teams or CROs.
• Collaborate with Clinical, Regulatory, and Data Management on study design and data review.
• Contribute statistical input to regulatory submissions and briefing documents.
• Review and provide input on clinical study reports and publications.
• Ensure compliance with ICH guidelines and regulatory standards.

Skills

PhD Biostatistics

5+ years experience

SAS and/or R

ICH E9 knowledge

CDISC ADaM

Adaptive trial designs

CRO oversight

Cross-functional leadership

Education

PhD in Biostatistics

Tools

SAS

R

CDISC ADaM

Job description

Beeline Medicines in the United States seeks an Associate Director, Biostatistics to provide statistical leadership across clinical development programs, shaping design, analysis plans, and regulatory submissions. You will oversee study design, sample size and analysis strategy from early development through submission.

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