Executive Director, Biostatistics

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 complement existing therapies and serve as transformative treatment options for significant patient populations living with cardioendocrine diseases.

Incubated by Third Rock Ventures, Marea completed a Series B financing in June 2024 and is well funded by a syndicate of leading life science investors including Sofinnova, Forbion, Xontogeny/ Perceptive Advisors, venBio, Omega Funds, Surveyor, Alpha Wave and Third Rock Ventures.

The company’s lead program, MAR
001, is a monoclonal antibody targeting ANGPTL4, a genetically validated target with potential to address the subset of patients at the highest risk of adverse cardiovascular events, despite current standard of care therapies. MAR
001 is rapidly progressing through Phase 2b clinical development. Our second clinical asset, MAR
002, is a monoclonal antibody targeting excess growth hormone produced by the pituitary gland in the rare hormonal disorder, acromegaly. MAR
002 has potential to become best-in-disease and is rapidly progressing through Phase 1 clinical development. We also have a third asset that is rapidly advancing through research discovery, with DC nomination expected next 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.

We are looking for an Executive Director, Biostatistics to join our team in a critical leadership position responsible for overseeing and directing biometrics activities related to the company’s clinical trials and other research activities. They will help guide the design, execution, and interpretation of preclinical and clinical studies to ensure that the results are aligned with corporate and regulatory requirements.

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

• Oversee operations and management of biometrics including statistics, statistical programming and data management
• Ensure statistical strategies align with company business objectives, such as those related to trial design and conduct, regulatory submissions, and scientific publications
• Define, institute, and oversee best practices regarding planning, execution, handling, and interpretation of scientific and clinical results to ensure high quality and compliant data handling and interpretation
• Work cross-functionally toward 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
• 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
• 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
• Ensure strong data handling and infrastructure, including ongoing evaluation and implementation of systems and vendors
• Collaborate with Clinical Operations and other teams to oversee/coordinate/support user acceptance testing (UAT) when electronic data capture (EDC) systems are being implemented for
• Review and approve study database specifications, data management plans, data transfer plans, CDISC and ADaM specifications, and ensures reviews as needed by other appropriate team members
• 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

• PhD in statistics or related field
• At least 15 years in related positions in pharmaceuticals/biotechnology, with increasing responsibility and which must include planning, analysis, and reporting of clinical trials
• Proven leadership of teams and vendors including statisticians, programmers, and data managers
• In-depth knowledge of all phases of the global drug development
• 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 in…