Biostatistics Strategy Lead – Clinical Trials

Penfield Search Partners Ltd.; Massachusetts; Hybrid; USD 150,000 - 190,000; Full time

Job summary

Penfield Search Partners Ltd. is seeking an Associate Director, Biostatistics in a hybrid model (Boston or Philadelphia) to provide statistical leadership for clinical development programs.

The role involves developing and implementing statistical strategies for trials and regulatory submissions, with close collaboration across functions and regulatory agencies. The ideal candidate holds a PhD or MS in Biostatistics, with extensive experience in drug development, regulatory submissions, and

Qualifications

• PhD or MS in Biostatistics or related field.
• Experience providing statistical leadership in drug development programmes.
• Experience enabling regulatory submissions and interactions with authorities.

Responsibilities

• Lead full scope of Biostatistics activities for a clinical development program.
• Define statistical strategy for study design and data analysis for trials and regulatory submissions.
• Influence clinical development plans and collaborate with cross-functional teams for governance reviews.
• Lead statistical strategy for study planning and execution as a member of executive teams.
• Provide quantitative evaluation supporting clinical trials, regulatory submissions, and related documentation.
• Represent Biostatistics in interactions with regulatory authorities (FDA/EMA/PMDA).
• Ensure timely and high-quality deliverables from CROs or internal providers.

Skills

Leadership

Clinical development strategy

Statistical leadership

Cross-functional collaboration

Education

PhD or MS in Biostatistics

Tools

SAS

R

Job description

Penfield Search Partners Ltd. is seeking an Associate Director, Biostatistics in a hybrid model (Boston or Philadelphia) to provide statistical leadership for clinical development programs.

The role involves developing and implementing statistical strategies for trials and regulatory submissions, with close collaboration across functions and regulatory agencies. The ideal candidate holds a PhD or MS in Biostatistics, with extensive experience in drug development, regulatory submissions, and