Senior Director, Biostatistics

Role Summary:

• The Sr. Director of Biostatistics provides leadership and strategic input for clinical development programs, overseeing statistical activities from trial design to analysis and interpretation.
• This hands-on role involves interacting with cross-functional teams, managing biometrics vendors, and supporting interactions with global health authorities.

Key Responsibilities:

• Lead the biometrics team at a program level, provide statistical input to strategic planning, study design, and regulatory documents.
• Author SAPs, develop specifications for derived variables and templates, and ensure high-quality data through collaboration with data managers.
• Oversee CRO/vendor deliverables, participate in global health authority interactions, and build efficient biostatistical processes.

Ideal Candidate:

• PhD in Biostatistics or related field with 10-12 years of experience in pharma, biotech, or CRO industry; strong knowledge of statistical methodologies and Bayesian methods preferred.
• Experience with regulatory submissions, proficiency in SAS and R, and familiarity with CDISC standards.
• Excellent communication, interpersonal, and organizational skills; ability to work independently in a matrixed organization.

What We Offer:

• Opportunity to work in a fast-paced, dynamic environment with market competitive compensation, including base salary, performance bonus, and equity grants.
• Unlimited PTO, two company-wide shutdowns, professional development opportunities, and a remote working environment with frequent in-person meetings.