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Senior Manager, Statistical Science

BioMarin Pharmaceutical Inc.
Brisbane, California
Start date
Sep 6, 2023

Job Details

Who We Are

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.


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 gene therapy 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

* Note: This job can be hybrid, remote, or onsite in Brisbane location


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.


  • PhD degree preferred, or MS in statistics, biostatistics or related discipline


  • 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
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.


BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.

Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.

Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.

Company info
United States

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