Senior Director Biostatistics

Morgan Prestwich - Life Science & Healthcare Executive Search; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Morgan Prestwich - Life Science & Healthcare Executive Search is seeking a senior biostatistics leader to drive strategic statistical direction for clinical development programs. You will design studies, review analysis plans, oversee internal statisticians and CRO partners, and contribute to regulatory submissions and publications.

The role requires mentoring the biostatistics team, coordinating cross-functional efforts, and representing the company in health authority interactions.

Qualifications

• Ph.D. or MS in Biostatistics, Statistics, or related field.
• Proven progression experience within Life Sciences.
• Proven experience leading statistical strategy for regulatory submissions and health authority interactions.
• Strong track record of managing and mentoring biostatistics teams and overseeing CRO partners.

Responsibilities

• Provide strategic statistical leadership for clinical development programs.
• Lead study design, statistical analysis plans, sample size calculations, and interpretation of results.
• Oversee internal statisticians and CRO partners to ensure high-quality, timely deliverables.
• Contribute statistical input to protocols, clinical study reports, regulatory submissions, and publications.
• Represent the company in health authority interactions and regulatory meetings.
• Collaborate with cross-functional teams (clinical, regulatory, data management, programming).
• Mentor, develop, and manage the biostatistics team, including resource planning and performance management.

Skills

Biostatistics leadership

CRO oversight

Regulatory submissions

Education

Ph.D. or MS in Biostatistics

Job description

• Provide strategic statistical leadership for clinical development programs
• Lead study design, statistical analysis plans, sample size calculations, and interpretation of results
• Oversee internal statisticians and CRO partners to ensure high-quality, timely deliverables
• Contribute statistical input to protocols, clinical study reports, regulatory submissions, and publications
• Represent the company in health authority interactions and regulatory meetings
• Collaborate with cross-functional teams (clinical, regulatory, data management, programming)
• Mentor, develop, and manage the biostatistics team, including resource planning and performance management

Qualifications:

• Ph.D. or M.S. in Biostatistics, Statistics, or related field
• Proven progression experience within Life Sciences
• Proven experience leading statistical strategy for regulatory submissions and health authority interactions
• Strong track record of managing and mentoring biostatistics teams and overseeing CRO partners