Director, Biostatistics

ABOUT THE ROLE

 Reporting to the Vice President, Biostatistics, the Director/Senior Director, Statistics will provide strategic and operational leadership across Marea Therapeutics’ clinical development programs.  This position will lead statistical activities across multiple studies, serve as the Biostatistics representative on clinical study teams, and oversee external CRO partners to ensure scientific rigor, regulatory compliance, and timely execution. The role combines hands-on statistical expertise with leadership to advance Marea’s clinical pipeline. 

This is a full-time, South San Francisco-based position with the expectation of working on-site at least three days per week.

 

KEY RESPONSIBILITIES

• Statistical planning for, and interpretation of, preclinical and clinical programs
• Work cross-functionally to find strategic and creative problem-solving for statistical approaches in studies, including researching new statistical methods to support program needs that align with regulatory and industry standards
• Ensure the statistical strategy aligns with the company’s business objectives which includes understanding the company’s goals when it comes to the regulatory submissions, scientific publications, and other corporate needs
• Collaborate with thought leaders and experts in the field to ensure that statistical methods and findings are in line with best practices and the latest scientific and statistical advancements
• Define, institute, and oversee best practices with regard to planning, execution, handling, and interpretation of scientific and clinical results to ensure high quality and compliant data handling and interpretation
• Ensure strong data handling and infrastructure, including ongoing evaluation and implementation of systems and vendors
• Identify, engage, and manage key biometrics vendors, consultants, and thought leaders (e.g., in statistics, programming, and data management)
• Provide statistical oversight and support global regulatory strategy, planning, submissions, and interactions
• Anticipate, identify, and assist in the resolution of risks, bottlenecks, and potential issues in biometrics-related activities
• Continually assess and plan for appropriate resourcing to meet approved biometrics initiatives
• Provide regular updates to cross-functional and leadership teams to ensure alignment, resourcing, and tracking

 

QUALIFICATIONS

• PhD with 10+ years biostatistics experience in the biotechnology or pharmaceutical industry.
• Expert in applied statistics, including the design and analysis of complex datasets, such as Experience in cardiovascular, metabolic diseases, and/or rare diseases is a plus
• Experience with multiple imputation and longitudinal data analysis.
• Proven leadership of teams and vendors including statisticians, programmers, and data managers
• In-depth knowledge of all phases of the global drug development
• Experience in supporting large, long-term studies and clinical development plans is a plus
• Demonstrated ability to work in a cross-functional environment
• Knowledge of global regulatory submission processes and able to provide support to the regulatory team
• Experience with supporting publications and communications strategies
• Strong verbal and written communication, presentation, and interpersonal skills to be effective in communicating and interacting with a diverse group of people
• Superb attention to detail
• Exceptional time and project management skills, with the ability to execute on plans under pressure in a small, fast-paced environment with tight deadlines
• High integrity and sense of urgency, with a desire to individually contribute and lead
• Highly motivated, proactive, enthusiastic and goal orientated
• The ability to anticipate potential pitfalls, and proactively solve problems
• The ability to work independently as well as coordinate and work with large cross-functional teams
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PAY RANGE

 The salary range for this role is $250,000 - $300,000. Compensation and title will be competitive and commensurate with the candidate's experience, qualifications, and the responsibilities of the position.