Job Description
A growing biotechnology company focused on innovative therapeutics is seeking a strategic and hands-on Senior Director of Biostatistics to provide statistical leadership across clinical development programs. This individual will serve as a key cross-functional partner supporting trial design, execution, analysis, and regulatory activities across early and late-stage studies.
This is a high-impact opportunity for someone interested in joining a collaborative environment, helping shape development strategy, and building biometrics infrastructure within a fast-paced biotech setting.
Key Responsibilities
- Lead biostatistical strategy and execution across clinical development programs, including Phase I-III studies
- Provide input into study design, interim analyses, endpoint strategy, and overall clinical development planning
- Support regulatory submissions and interactions through statistical analysis and document review
- Develop and oversee SAPs, TFLs, randomization strategies, and statistical deliverables
- Partner closely with Clinical Development, Data Management, Regulatory, and external vendors/CROs
- Ensure high-quality statistical oversight and adherence to regulatory and industry standards
- Help establish and refine internal biometrics processes and best practices
- Initially operate as a lead individual contributor with future opportunity to help build and mentor a broader biometrics function
- Stay current on emerging statistical methodologies and regulatory guidance
Qualifications
- PhD in Biostatistics, Statistics, or related field with significant industry experience; MS candidates with additional experience also considered
- Strong clinical trial experience within biotech or pharmaceutical environments, particularly across Phase II and III studies
- Deep understanding of statistical methods used in clinical development and regulatory submissions
- Experience developing SAPs and working with CDISC standards including SDTM and ADaM
- Familiarity with FDA, EMA, and ICH guidance
- Experience supporting biomarker analyses and innovative trial designs is a plus
- Proficiency with SAS and familiarity with R and/or Python
- Strong communication and collaboration skills within cross-functional environments