Director in Statistical Science

Overview

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BioMarin is a global biotechnology company that translates genetic discoveries into new medicines that advance human health. Our Worldwide Research and Development (WWRD) engine covers bench and clinical research from discovery to post-market development, aiming to create first-in-class and best-in-class therapeutics for genetic diseases.

Biostatistics Program Lead

As a Biostatistics Program Lead, the Director provides Data Science and statistical leadership for an assigned clinical development program.

Responsibilities

• Cross-Functional Leadership: Ensure Data Science functional and cross-functional teams (Statistical Analysis and Review Team, SART; Data Analysis and Review Team, DART) operate per charters, enabling collaboration, communication, and expert input into program deliverables.
• Cross-Functional Representation: Act as Data Science primary representative on key teams (CDT, MAPT); liaise between teams and Data Science for Data Science matters related to the product.
• Communication and Alignment: Facilitate timely communication among CDT/MAPT, Data Science, and Study teams on Data Science issues.
• Strategic Initiatives: Participate in or lead Data Science-wide strategic changes or improvement initiatives.
• SOPs and Guidelines: Develop SOPs, work instructions, guidelines, and templates.

• People/Professional Leadership: Participate in recruiting, hiring, promotions, and team management for any managed staff; mentor Biostatistics staff on performance and career development; stay current with literature and advancements; advocate for training and tools to enhance Biostatistics skills.

• Biostatistics Strategy, Deliverable Development, and Execution: Monitor program progress; allocate resources for deliverables; produce or supervise preparation of study protocols, SAPs, data analyses, manuscripts, clinical study reports, and regulatory submissions; oversee CRO performance and standard reporting programs; collaborate with clinical scientists, statisticians, and operations to plan and analyze studies; review statistical content for abstracts/manuscripts/publications; escalate Data Science issues to cross-functional teams and management.

• Clinical Development Focus: Provide SME leadership in statistics for design of clinical development plans; represent Biostatistics in regulatory meetings and respond to agency questions; lead statistical input for regulatory submissions (NDA/BLA); contribute to filing strategy as appropriate.

• Medical Affairs, RWE, and Market Access Focus: Provide statistical leadership for interactions with regulatory/HTA agencies and healthcare professionals; support or lead publication efforts; maintain knowledge of competitive landscape and product positioning; share insights with the team.

• Education: PhD preferred, or MS in statistics, biostatistics, or related discipline.

• Experience: 9+ years of clinical trial/RWE experience in pharmaceutical/biotech with PhD (11+ years with MS); experience with statistical analysis plans, study protocols, CSRs, ICH/CTA submissions; 3+ years of people management.

Note: This description is not intended to be all-inclusive. It describes the general nature of the job and may include other duties as assigned.

Equal Opportunity Employer/Veterans/Disabled. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Seniority level

• Director

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

Industries

• Biotech/Pharmaceutical