Senior Manager, Biostatistics

Responsibilities include contributing to protocol design, developing statistical analysis plans, and analyzing complex, often high-dimensional and/or observational data to inform clinical plans, go/no-go decisions and regulatory interactions. Successful candidate will combine solid statistical background with advanced machine learning techniques to help to transform how Cytokinetics generates insights from clinical trials and other biomedical datasets.

Essential Duties and Responsibilities

• Under guidance, provide statistical support and strategic input to clinical development plans and target product profiles, proof of concept criteria, and Phase 1-4 trials designs, contributing to team's preparation for company governance reviews.
• Draft and review protocols, SAPs, and CRFs using established templates and examples, ensuring alignment with trial goals such as safety and efficacy assessments and translational objectives.
• Perform or support statistical analyses per SAPs, including working with novel endpoints or biomarkers, and proactively identify future uncertainties.
• Collaborate with study teams to meet deliverables and develop appropriate processes.
• Summarize findings clearly, with support as needed, translating complex outputs into actionable insights.
• Contribute to clinical study reports and regulatory submissions, supporting documentation for relevant regulatory interactions including INDs, EMA scientific advice, and other HA interactions.
• Apply judgment to solve moderately complex statistical or data issues, and know when to seek guidance when facing novel or ambiguous situations.
• Be an active participant in department initiatives contributing to 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.
• Play an active part in internal innovation by evaluating novel approaches, supporting capability building, and aligning with Cytokinetics AI/ML efforts.

Education/Experience/Knowledge & Skills

• Ph.D. or M.S. in Statistics/Biostatistics, a minimum of 0-2 years (for Ph.D.) or 5+ years (for M.S.) of experience in the biotech/pharma industry or at research institutions as a statistician.
• Possess a solid technical foundation in statistics.
• Proficient in SAS and/or R and generally comfortable with programming concepts.
• Demonstrate independent thinking and make decisions based on sound principles.
• Demonstrate excellent strategic agility including problem solving and critical thinking, with agility that extends beyond the technical domain.
• Have excellent verbal and written communication skills in presentation and writing, with the ability to explain complex technical concepts in clear language.

Preferred Qualifications

• Experience working with cross-functional collaborators.
• Effective communication skills with the ability to translate complex, often exploratory or model-based statistical concepts for non-statistical audiences, including clinicians and researchers.
• Basic understanding or willingness to learn drug development principles.
• Ability to providing statistical guidance in fast-paced, high-uncertainty settings.
• Familiarity with ML and AI approaches.