Biostatistics Lead, Clinical Trials (Hybrid)

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

Benefits offered by this job

Health coverage

Paid time off

Hybrid schedule

Location benefits

Job summary

Beeline Medicines in the United States is seeking an Associate Director, Biostatistics to provide statistical leadership across clinical development programs. You will shape protocol design, SAPs, sample size considerations and analysis strategy, ensuring high-quality deliverables for regulatory submissions.

The role requires clear communication with clinical, regulatory and executive audiences, and involves collaboration with CROs.

Qualifications

• PhD in Biostatistics, Statistics or related quantitative discipline required.
• 5 years biostatistics experience in pharma/biotech/CRO settings preferred.
• Experience in immunology, inflammation or related therapeutic areas preferred.
• Advanced proficiency in SAS and/or R for analysis and programming.
• Strong knowledge of clinical trial design, ICH E9 and CDISC ADaM standards.
• Experience with adaptive trial designs, interim analyses and Bayesian or frequentist methods.
• Experience with CRO oversight and governance in outsourced development.

Responsibilities

• Lead statistician for one or more clinical studies from protocol design to study report.
• Develop SAPs, sample size/power calculations and randomization schemes.
• Oversee production and QC of tables, listings and figures (TLFs).
• Collaborate with Clinical, Regulatory and Data Management on study design and data review.
• Contribute statistical input to regulatory submissions and briefing documents.
• Review clinical study reports and publications for statistical accuracy.

Skills

Leadership

Biostatistics expertise

Study design

Regulatory submissions

SAS

R

ICH E9

CDISC ADaM

Adaptive trial designs

Bayesian methods

Cross-functional collaboration

Education

PhD in Biostatistics or related field

Job description

Beeline Medicines in the United States is seeking an Associate Director, Biostatistics to provide statistical leadership across clinical development programs. You will shape protocol design, SAPs, sample size considerations and analysis strategy, ensuring high-quality deliverables for regulatory submissions.

The role requires clear communication with clinical, regulatory and executive audiences, and involves collaboration with CROs.