Position Summary
The Executive Director, Biostatistics leads the design, development, and evaluation of statistical and technical components that drive the efficient execution and analysis of clinical trials. Serving as the lead statistician on assigned studies, this role provides senior-level statistical expertise and strategic guidance to the Biometrics function.
The incumbent ensures the statistical rigor, quality, and integrity of clinical trial data produced by internal teams and external partners, and contributes to study protocols, statistical analysis plans, clinical study reports, and the interpretation of analytic results. This position advances the company’s research and development objectives by supporting high-value therapeutic programs aimed at addressing unmet medical needs.
Essential Duties & Responsibilities
Strategic Leadership
- Provide strategic direction for the statistical function, establish performance objectives, and ensure adequate statistical support across all project teams.
- Work effectively with complex and abstract concepts across multiple business functions, evaluating intangible variables to identify fundamental issues and set strategic direction for major functional areas.
- Keep senior management informed of progress, risks, and issues affecting project and organizational objectives.
Clinical Trial Design & Analysis
- Provide leadership and oversight to ensure the statistical integrity of clinical trial design, data analysis, and reporting.
- Guide the development and application of innovative clinical trial designs to improve operational efficiency and support drug development objectives.
- Provide statistical leadership for regulatory submissions, clinical development plans, and out-licensing activities, proactively identifying and resolving issues arising during study conduct.
External Partnerships & Standards
- Build and maintain external relationships with academic and regulatory statisticians, including FDA partners, to support regulatory strategy and best practices.
- Oversee the development, maintenance, and application of departmental processes, standards, and SOPs.
People & Resource Management
- Manage and develop statistical staff through mentoring, recruiting, performance management, and goal setting.
- Own departmental budgeting and resource planning.
- Perform other related duties as required.
Qualifications & Experience
Education
- PhD in Biostatistics or a related field, or an MS in Biostatistics, required.
Experience
- 12+ years of relevant experience with a PhD, or 15+ years with a Master’s degree.
- Minimum of 6 years of direct people management responsibility.
- Demonstrated experience leading statistical strategy for NDAs, BLAs, and PMAs.
Technical Expertise
- Deep expertise in adaptive clinical trial designs and advanced statistical methodologies, supported by an established publication record in innovative trial design and statistical methodology.
- Extensive experience with FDA and ICH regulatory frameworks and guidance.
- Expert proficiency in SAS, with demonstrated ability to leverage complementary statistical tools as appropriate.
- Advanced capability in evaluating and guiding technical solutions across statistics, programming, and data management.
Leadership & Communication
- Proven ability to influence and advise senior leaders and external stakeholders.
- Strong organizational and portfolio-level execution capabilities.
- Exceptional written and verbal communication skills.
- Demonstrated leadership in building, developing, and sustaining high-performing teams.
Nektar currently anticipates the base salary for the Executive Director, Biostatistics to range from $350,000 to $400,000 for candidates in the Bay Area and will depend, in part, on successful candidate's location and qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company's discretion on an individual basis.) The compensation described above is subject to change and could be higher or lower than the range described based on the market survey data.
Qualifying employees are eligible to participate in benefit programs such as:
Health Insurance (Medical/Dental/Vision)
Disability Insurance
Holiday Pay
Paid Time Off (PTO)
401(k) Match
Employee Stock Purchase Plan
Wellness Programs
Parental Leave Benefits (in accordance with the terms of applicable plans)
For general information on company benefits, please go to https://www.nektar.com/careers.
