Director in Statistical Science

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.

• Lead Data Science statistical planning and analysis efforts for the program across Data Science and on key cross-functional teams
• Lead the production of Data Science deliverables for the program, either personally or by supervising one or more statisticians
• Provide leadership and oversight for all Data Science deliverables, including regulatory/HTA submissions
• May also be the Study Lead Statistician for important clinical study protocols

• Accountable for ensuring key Data Science functional and cross-functional program teams (Statistical Analysis and Review Team (SART) and Data Analysis and Review Team (DART)) are functioning according to team charters to ensure appropriate cross-functional collaboration, communication, and expert input into program deliverables and outcomes
• Act as Data Science primary representative on key cross-functional teams (CDT, MAPT) as a standing member and liaise between the team and Data Science functions for all Data Sciencematters regarding the product
• Ensure timely and effective communication and alignment among the CDT/MAPT, Data Science management/team, and the Study team members on all the Data Science issues
• Participate in or lead elements of key Biostatistics and/or Data Science -wide strategic change or improvement initiatives
• Develop SOPs, WIs, guidelines, and templates

• Participate in recruiting, hiring, promotions, and team management efforts, in collaboration with Biostatistics leadership and HR, for any managed staff
• Mentor and guide managed Biostatistics staff on performance and career development
• Keep abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program
• Identify and advocate for training and tools in support of Biostatistics skill development

• Monitor program progress and ensure proper resource allocation for successful project deliverables against goals and timelines
• Produce the following program and study-related deliverables, either personally or by supervising one or more statisticians: appropriate sections of study protocols, case report forms, statistical analysis plans, data analyses, manuscripts, and sections of clinical study reports and registration documents
• Participate in the oversight of the performance of Contract Research Organizations (CROs) supporting the program and developing standard reporting programs and standard CRFs in collaboration with cross-functional groups within the Data Science Department
• Work with clinical scientists, statistical programmers, clinical operations, and other statisticians to plan clinical studies and to analyze and interpret clinical study data
• Review and provide statistical content or review comments, as requested, on company-sponsored abstracts, manuscripts, and publications related to the product
• Identify and escalate strategic Data Science issues/challenges relevant to a program to key cross-functional teams/forums (CDT/MAPT) as well as to Data Sciencemanagement for review, discussion, and mitigation planning

• Participate in new drug development programs as a Subject Matter Expert (SME) in statistics area and provide statistical leadership in the design of clinical development plans
• Represent Biostatistics in meetings with regulatory agencies and prepare 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
• Support or lead filing efforts, as appropriate, including representing Biostatistics on the cross-functional filing team and contributing to filing strategy

• Provide statistical leadership for preparation and support of team interactions with regulatory/HTA agencies and HCPs
• Represent Biostatistics in meetings with regulatory/HTA agencies and prepare oral/written responses to agency questions, as needed
• Support or lead Biostatistics, Medical Affairs/RWE/Medical Access publication efforts, as appropriate, including representing Biostatistics on the cross-functional team and contributing to Medical Affairs/RWEW/Medical Access publication strategy and plan
• Develop and maintain current knowledge and understanding of competitive environment and BioMarin product positioning vs. competitors for relevant products through research and discussions with other stakeholders; share knowledge with team

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

• 9+ years clinical trial / RWE experience in pharmaceutical and/or biotech company with PhD; 11+ 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.
• 3 or more years of people management experience

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.

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.