At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact.

The VP of Biometrics, reporting to SVP of Development Operations, will be the spoke person and responsible for successful strategic positioning and tactical advancement of Biometrics. This role is managing all Biometrics functions, including Biostatistics, Data Management, Statistical Programming, and Clinical Systems. Supports the development/documentation of procedures and policies for the operations. Participates in establishing drug development strategy and direction. This executive role works closely with drug development partners and participates in strategizing and executing the clinical development programs with a strong technical, regulatory, and scientific foundation to define the most effective approach across Cytokinetics’ R&D pipeline.

Responsibilities 

• Define and execute the strategic vision for the Biometrics Department.
• Establish organizational structure for biometrics department, including Biostatistics, Statistical Programming, Data Management, and Clinical Systems functions. Lead and develop Biometrics employees.
• Oversee and coordinate all biometrics activities to support of clinical development projects as well as deliver innovative study designs and analysis plans, ensuring sound biometrics principles and compliance with regulatory guidelines.
• Advises on statistical issues associated with the design and analysis of clinical trials and responsible for biometrics input on all major documents including, clinical development plans, protocols, data collection methodologies, clinical study reports and summaries of clinical safety and efficacy for regulatory filings.
• Guide application of epidemiologic methods to analyze observational/real world data to strengthen submission evidence and support drug development.
• Provides review and guidance on statistical aspects, new programming, database technologies, clinical systems and standards of all FDA/EMEA regulations and ICH & GCP guidelines.
• Senior biostatistics representative supports protocol/clinical document review, strategic- and partner joint- development activities, drug safety, and publication activities.
• Collaborate with other senior development leaders ensure consistency of development work standards intellectually, challenging assumptions and sharing ideas.
• Provide leadership for sponsor/CRO activities, relationships and escalation resolution.
• Interact with FDA/EMA and other health authorities to ensure clinical studies meet regulatory requirements and to ensure ongoing agreement on project development.
• Support the development and implementation of best practices, SOPs, standards, work instructions and policies for biostatistics.

Qualifications 

• Ph.D. in Statistics or related fields and 15+ years of pharmaceutical industry experience or Master in Statistics and 20+ years of comparable experience
• Expert knowledge of ICH and other regulatory development guidelines.
• Experience in recruiting, coaching, and developing talented team members.
• Deep understanding of mathematical and statistical principles; demonstrated proficiency in at least one statistical analysis software (SAS preferably). Knowledge of other statistical software is a plus.
• Experience in clinical development of wide range of therapeutic areas is a plus.
• Stellar communication and presentation skills. Must be able to articulate with non-statisticians to interpret and explain statistical findings.
• Excellent organizational and problem-solving skills.
• Proven leadership skills and must work effectively in a team environment.
• Knowledge of good biometrics procedures is desired.