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Marea Therapeutics · 1 day ago

Executive Director, Biostatistics

South San Francisco, CA

Full-time

Hybrid

Director/Executive

$290K/yr - $310K/yr

15+ years exp

Marea Therapeutics is a clinical-stage biotechnology company focused on developing innovative therapies for cardioendocrine diseases. The Executive Director of Biostatistics will lead biometrics activities related to clinical trials, ensuring alignment with corporate and regulatory standards while overseeing statistical strategies and data management.

BiotechnologyGeneticsLife Science

Responsibilities

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

Qualification

PhD in statisticsGlobal drug developmentLeadership of teamsClinical trial planningRegulatory submission processesCardiovascular disease experienceCommunication skillsProject management skillsProblem-solving abilityAttention to detail

Required

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

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

Ability to anticipate potential pitfalls and proactively solve problems

Ability to work independently plus coordinate and work with large cross-functional teams