Director, Biostatistics

Cytokinetics, Inc.; United States; On-site; USD 242,100 - 282,450; Full time

Benefits offered by this job

Stock options

Restricted stock units

Health, dental, vision, life and long‑

401k with employer match

Learning and wellness stipends

Paid time off

Job summary

Cytokinetics, Inc. is seeking a lead statistician to drive statistical leadership for clinical development and study designs. You will serve as SME in Biostatistics, guiding analyses across Phase 1‑4 trials and collaborating with multiple functions to ensure rigorous methods and regulatory readiness.

You will combine trial expertise with machine learning to extract insights from clinical data, enabling informed development decisions and interactions with regulators and payers.

Qualifications

• Ph.D. or M.S. in Statistics/Biostatistics with 8+ years (Ph.D.) and 12+ years (M.S.) biotech/pharma experience.
• Hands‑on 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 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 lead projects and mentor junior colleagues.

Responsibilities

• Provide statistical leadership for clinical development plans and trials, contributing to governance reviews.
• Represent Biostatistics on cross-functional teams and act as lead statistician on studies.
• Collaborate on study design, SAP, and analysis specifications with other functions.
• Guide DMC planning and coordination with independent statistical data analysis centers.
• Support data management, clinical operations, and database development activities.
• Ensure appropriate programming and outputs for datasets and analyses per protocols.
• Contribute to regulatory submissions and health authority communications.
• Support primary and secondary publications and data interpretation.
• Address methodological challenges and explore multimodal data (biomarkers, imaging, real‑world data).
• Drive department initiatives, best practices, and AI/ML alignment across Cytokinetics.

Skills

Statistics expertise

Biostatistics

Machine learning

Leadership

Communication

Education

Ph.D. in Statistics/Biostatistics

M.S. in Statistics/Biostatistics

Job description

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.

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.

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.

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.

Pay range

The expected salary range for this position based on the primary location of South San Francisco, CA is $242,100-$282,450.

Benefits

• Base salary is just one component of our competitive total compensation package, which includes equity in the form of stock options and/or restricted stock units, comprehensive health, dental, vision, life and disability insurance coverage, 401k retirement benefits with employer match, learning and wellness stipends, and paid time off.

Note that benefits are subject to change and may vary based on jurisdiction of employment.

Our employees come from different backgrounds, and we celebrate those differences.

We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.

Cytokinetics is an Equal Opportunity Employer.

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.