Sr Manager, Biostatistics (Study Lead)

Company: BioMarin Pharmaceutical Inc.
Location: San Rafael
Posted on: November 29, 2025

Job Description:

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Worldwide Research and Development From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. Biostatistics Study lead: As a Statistical Science Study Lead, the Senior Manager is responsible for leading and managing all Statistical Science-related activities for one or more studies of a comprehensive program to ensure high-quality deliverables are executed in line with agreed timelines. Provide statistical leadership, as a member of cross-functional study team, during protocol development (study design, sample size justification, and safety/efficacy analysis methods) and throughout study duration Collaborate with key stakeholders on study design and develop statistical analysis plan Analyze and validate data to support study deliverables, including filings, reports, publications, and presentations. Provide leadership and oversight for all Data Science deliverables for the study RESPONSIBILITIES For an assigned study, the Statistical Science Study Lead will perform a range of the following responsibilities: Cross-Functional Leadership Chair, or select a delegate to chair, Data Science functional and cross-functional program teams (Statistical Analysis and Review Team (SART) according to team charters to ensure appropriate cross-functional collaboration, communication, and expert input into program deliverables and outcomes Communicate Statistical Science and/or Data Science guidance as a representative or lead representative in cross-functional study teams (e.g., Study Execution Team) Statistical Science Deliverable Development and Execution Lead, and collaborate with others in Data Science, in the development of the statistical analysis plan (SAP) for the study including endpoint definition, sample size justification and statistical methodology; lead the execution of statistical analysis activities as outlined in the SAP and the related quality review and approval of deliverables Collaborate with others in Data Science and cross-functional stakeholders on study design Develop, and/or contribute to the development of, the following study-related deliverables: appropriate sections of study protocols, case report forms, data quality review and analyses, manuscripts, and sections of clinical study reports Contribute to and negotiate study timeline with cross-functional team; identify Statistical Science study resource needs to meet timeline Provide statistics area expertise to study team activities and deliverables Serve as the statistical expert for the study throughout the study lifecycle and ensure accuracy and reliability of statistical results for the entire study Work with cross-functional study team members (SET), other key stakeholders, and statisticians to analyze and interpret clinical study data Identify and manage issues and risks and escalate, as appropriate Keep abreast of literature/advancements in science/medicine/technology in own and related fields of the program Understand and follow Statistical Science processes for study execution for all Statistical Science-related study deliverables Develop SOPs, WIs, guidelines, and templates Clinical Development Focus Lead or support activities to prepare for meetings with regulatory agencies, including oral/written responses to agency questions, as needed Provide statistical leadership for preparation of marketing applications (e.g., NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies and other regulatory submissions (such as IND safety update, PSUR) Ensure the quality of data and accuracy of analyses in regulatory interactions (e.g. submissions) or publications Subject Matter Expertise The Senior Manager will be a subject matter expert. This position will contribute to and make an impact on the department and the cross-functional process. EDUCATION PhD degree preferred, or MS in statistics, biostatistics or related discipline EXPERIENCE 3 years clinical trial experience in pharmaceutical and/or biotech company with PhD; 6 years with MS Must have worked on statistical analysis plans, study protocols, clinical study reports, integrated summary of safety and efficacy reports, Investigator Brochures, and annual reports (or periodic safety update reports), electronic NDA and/or BLA submissions via eCTD, IND, CTA, or HTA interactions Strong programming skills in SAS, R, and other statistical software packages Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. 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.

Keywords: BioMarin Pharmaceutical Inc., San Rafael , Sr Manager, Biostatistics (Study Lead), Science, Research & Development , San Rafael, California