Director, Biostatistics

BioSpace; South San Francisco (CA); On-site; USD 250,000 - 300,000; Full time

Job summary

Marea Therapeutics in South San Francisco seeks a Director/Senior Director of Biostatistics to lead statistical activities across multiple studies, oversee CROs, and ensure regulatory compliance. This full-time, on-site role reports to the Vice President, Biostatistics, and combines hands-on statistics with leadership.

The position requires a PhD with 10+ years in biostatistics, experience in cardiovascular/metabolic/rare diseases, and proven ability to manage teams and external partners while

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

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

Skills

Biostatistics leadership

Clinical trial statistics

Statistical programming

Cross-functional collaboration

Regulatory submissions

Education

PhD in Biostatistics or related field

Job description

About The Company

Marea Therapeutics is a clinical-stage biotechnology company based in South San Francisco with a growing pipeline of first-in‑class therapies to address genetically validated cardioendocrine disease targets. Our therapies have the potential to serve as transformative treatment options for significant patient populations living with cardioendocrine diseases.

About The Company

Marea Therapeutics is a clinical-stage biotechnology company based in South San Francisco with a growing pipeline of first-in‑class therapies to address genetically validated cardioendocrine disease targets. Our therapies have the potential to serve as transformative treatment options for significant patient populations living with cardioendocrine diseases.

The company’s lead program, MAR001, is being developed for the treatment of severe hypertriglyceridemia (sHTG), a condition characterized by very high triglyceride levels and elevated risk of acute pancreatitis. Preclinical models with MAR001 demonstrated reduction in triglycerides, remnant cholesterol and ectopic fat, and improved insulin sensitivity. MAR001 has demonstrated strong and a differentiated profile in patients and is approaching Phase 3 development. Our second clinical asset, MAR002, is a monoclonal antibody targeting excess growth hormone produced by the pituitary gland in the rare hormonal disorder, acromegaly. MAR002 has potential to become best-in-disease and is quickly progressing into Phase 2/3 clinical development. We also have a third asset that is swiftly advancing through research discovery, with DC nomination expected this year.

At Marea, we believe in the power of collaboration and the importance of leading by example. We are a tight-knit team that values the contributions of every member, from interns to senior leaders. Our environment is dynamic, with each day presenting new challenges and opportunities for growth. Every role is "Hands-On", and the successful candidate will be able to work alongside team members, regardless of level, to understand challenges and drive results.

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

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.

We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual’s status in any group or class protected by applicable federal, state, and local law. We invite applications from minorities, women, the disabled, protected veterans, and all other qualified applicants.