Biostatistics Lead, Clinical Development

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

Benefits offered by this job

Health and wellness coverage

Paid time off

Job summary

Beeline Medicines is seeking an Associate Director, Biostatistics to lead statistical strategy for clinical development, design studies, plan analyses, and oversee deliverables from CROs. You will partner with cross‑functional teams and ensure outputs meet ICH and regulatory expectations.

The role requires a PhD in Biostatistics and at least five years in pharma/biotech stats, with strong SAS or R skills, Bayesian/frequentist methods, and experience with adaptive trials.

Qualifications

• PhD in Biostatistics, Statistics, or a closely related quantitative discipline required.
• 5 years of biostatistics experience in pharma/biotech/CRO settings preferred.
• Experience in immunology 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.
• Experience with adaptive trial designs and interim analyses.
• Experience with CRO statistical oversight and governance.

Responsibilities

• Serve as lead statistician for one or more clinical studies from protocol to CSR.
• Develop SAPs, sample size/power calculations, and randomization schemes.
• Oversee tables, listings, and figures (TLFs) with CROs or in-house.
• Collaborate on study design, protocol development, and data review.
• Contribute statistical input to regulatory submissions and briefing documents.
• Review clinical study reports and publications for statistical accuracy.
• Ensure compliance with ICH guidelines and regulatory standards.
• Perform other duties as assigned.

Skills

Statistical leadership

SAS

R

Trial design

ICH E9

CRO oversight

Cross-functional comms

Bayesian methods

Education

PhD in Biostatistics

Tools

SAS

R

Job description

Beeline Medicines is seeking an Associate Director, Biostatistics to lead statistical strategy for clinical development, design studies, plan analyses, and oversee deliverables from CROs. You will partner with cross‑functional teams and ensure outputs meet ICH and regulatory expectations.

The role requires a PhD in Biostatistics and at least five years in pharma/biotech stats, with strong SAS or R skills, Bayesian/frequentist methods, and experience with adaptive trials.