Director, Biostatistics
Cytokinetics
August 20, 2026
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Responsibilities:
- Provide statistical support and strategic input to clinical development plans and target product profiles, proof of concept criteria, and Phase 1–4 trial designs.
- Represent Biostatistics on cross-functional program teams; serve as lead statistician for studies.
- Collaborate on study design, protocol development, statistical analysis plan (SAP) and analysis specifications.
- Support protocol development and SAP/specifications via direct involvement and guidance to junior staff.
- Plan and prepare DMC materials; coordinate DMC reviews with an independent statistical data analysis center.
- Partner with data management and clinical operations on database development, data collection, and cleaning.
- Work with statistical programming to ensure correct dataset/output programs and that analyses follow protocols/SAPs.
- Provide statistical input for global health authority documents and responses.
- Support primary/secondary publications and assist with accurate data interpretation.
- Address methodological challenges in exploratory clinical research; integrate multimodal data (e.g., biomarkers, imaging, real-world data).
- Drive department initiatives, best practices, and guidelines; stay current on statistical/drug development/regulatory guidance.
- Propose and evaluate novel approaches aligned with AI/ML efforts.
Qualifications/Skills:
- Ph.D. or M.S. in Statistics/Biostatistics; minimum 8 years (Ph.D.) or 12 years (M.S.) biotech/pharma statistical experience.
- Hands-on experience designing/analyzing clinical trials and applying machine learning.
- Solid knowledge of ICH and other biostatistical regulatory requirements.
- Strong verbal/written communication and collaboration; ability to work independently; ability to identify business-relevant questions, lead projects, and mentor.
- Proficiency in R.
Preferred Qualifications:
- Leading disease-area statistical strategy; enterprise initiative experience across Clinical Development, Clinical Pharmacology, Translational Medicine, Regulatory, and Biomarker teams.
- Familiarity with AI/ML and diverse data sources.
- Contributions to external working groups or published statistical innovation.
Application instructions:
- Please review the GDPR policy PRIOR to applying.
- Provide statistical support and strategic input to clinical development plans and target product profiles, proof of concept criteria, and Phase 1–4 trial designs.
- Represent Biostatistics on cross-functional program teams; serve as lead statistician for studies.
- Collaborate on study design, protocol development, statistical analysis plan (SAP) and analysis specifications.
- Support protocol development and SAP/specifications via direct involvement and guidance to junior staff.
- Plan and prepare DMC materials; coordinate DMC reviews with an independent statistical data analysis center.
- Partner with data management and clinical operations on database development, data collection, and cleaning.
- Work with statistical programming to ensure correct dataset/output programs and that analyses follow protocols/SAPs.
- Provide statistical input for global health authority documents and responses.
- Support primary/secondary publications and assist with accurate data interpretation.
- Address methodological challenges in exploratory clinical research; integrate multimodal data (e.g., biomarkers, imaging, real-world data).
- Drive department initiatives, best practices, and guidelines; stay current on statistical/drug development/regulatory guidance.
- Propose and evaluate novel approaches aligned with AI/ML efforts.
Qualifications/Skills:
- Ph.D. or M.S. in Statistics/Biostatistics; minimum 8 years (Ph.D.) or 12 years (M.S.) biotech/pharma statistical experience.
- Hands-on experience designing/analyzing clinical trials and applying machine learning.
- Solid knowledge of ICH and other biostatistical regulatory requirements.
- Strong verbal/written communication and collaboration; ability to work independently; ability to identify business-relevant questions, lead projects, and mentor.
- Proficiency in R.
Preferred Qualifications:
- Leading disease-area statistical strategy; enterprise initiative experience across Clinical Development, Clinical Pharmacology, Translational Medicine, Regulatory, and Biomarker teams.
- Familiarity with AI/ML and diverse data sources.
- Contributions to external working groups or published statistical innovation.
Application instructions:
- Please review the GDPR policy PRIOR to applying.