Director, Biostatistics

Playing a critical role as a lead statistician for clinical program(s) and studies and the subject matter expert (SME) in Biostatistics within Biometrics function, this position is to provide statistical leadership and support for clinical development strategy and clinical studies through product life cycle. This role ensures scientific rigor while maintaining the flexibility needed for hypothesis generation and signal detection.

Responsibilities include contributing to protocol design, and to clinical development and statistical analysis plans, as well as conducting exploratory analyses to inform development decisions and interactions with regulators and payers. Successful candidate will combine deep clinical trial expertise with advanced machine learning to transform how Cytokinetics generates insights from clinical trials and other biomedical datasets. 

Essential Duties and Responsibilities 

• Provide statistical support and strategic input to clinical development plans and target product profiles, proof of concept criteria, and Phase1-4 trials designs, contributing to team’s preparation for company governance reviews. 

• Represent Biostatistics function on cross-function teams at program level and serve as a lead statistician on the studies. 

• Collaborate with various functions on study design and planning, protocol development, statistical analysis plan and analysis specifications. 

• Provide statistical support for study protocol development, analysis plan and specification through direct involvement and/or providing guidance to junior staff. 

• Plan and prepare independent data monitoring committee (DMC), coordinate with independent statistical data analysis center for DMC and study team for periodic DMC reviews. 

• Collaborate with data management and clinical operations over the course of clinical studies to provide statistical input to study conducts and database development as well as data collection and cleaning activities. 

• Collaborate with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation, and ensure the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately. 

• Provide statistical input and leadership to the development of global health authority documents, regulatory interaction and response to health authority submissions. 

• Provide statistical support for primary and secondary publications, assist in data interpretation to ensure consistency and accuracy in data presentation. 

• Anticipate and address methodological challenges in exploratory clinical research, guiding the integration of multimodal data (e.g., biomarkers, imaging, real-world data)  

• Drive and lead department initiatives, best practices, and guidelines. 

• Keep abreast in new developments in statistics, drug development, and regulatory guidance and share knowledge with functional and cross-functional team members. 

• Actively contribute to internal innovation by proposing and evaluating novel approaches, supporting capability building, and aligning with Cytokinetics AI/ML efforts 

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: 

Education/Experience: 

• Ph.D. or M.S. in Statistics/Biostatistics, a minimum of 8 years (for Ph.D.) and 12 years (for M.S.) of experience in the biotech/pharma industry as a statistician.  

• Hands-on experience in design and analysis of clinical trials and applying machine learning tools is a must. 

• Ability to work independently and within a team. 

• Solid knowledge in ICH and other regulatory requirements related to biostatistical activities and clinical trials. 

• Excellent verbal and written communication skills are required. 

• Great interpersonal and collaborative skills are essential. 

• Demonstrated interest and ability to proactively identify business relevant questions, lead projects and mentor junior colleagues 

• Proficiency in R  

Preferred qualifications 

• Experience leading disease area statistical strategy or acting as a statistical representative in enterprise-level initiatives across Clinical Development, Clinical Pharmacology, Translational Medicine, Regulatory, and Biomarker teams 

• Familiarity with AI/ML, and experience with diverse data sources   

• Contributions to external working groups, scientific collaborations, or published statistical innovation  

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