Job Details

Biostatistics Program Lead

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

Responsibilities include:

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

Additional responsibilities include:

• Accountable for ensuring key Data Science functional and cross-functional program teams are functioning according to team charters to ensure appropriate cross-functional collaboration, communication, and expert input into program deliverables and outcomes
• Acting as Data Science primary representative on key cross-functional teams as a standing member and liaising between the team and Data Science functions for all Data Science matters regarding the product
• Ensuring 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
• Participating in or leading elements of key Biostatistics and/or Data Science-wide strategic change or improvement initiatives
• Developing SOPs, WIs, guidelines, and templates

People/Professional Leadership:

• Participating in recruiting, hiring, promotions, and team management efforts, in collaboration with Biostatistics leadership and HR, for any managed staff
• Mentoring and guiding managed Biostatistics staff on performance and career development
• Keeping abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program
• Identifying and advocating for training and tools in support of Biostatistics skill development

Biostatistics Strategy, Deliverable Development, and Execution:

• Monitoring program progress and ensuring proper resource allocation for successful project deliverables against goals and timelines
• Producing 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
• Participating 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
• Working with clinical scientists, statistical programmers, clinical operations, and other statisticians to plan clinical studies and to analyze and interpret clinical study data
• Reviewing and providing statistical content or review comments, as requested, on company-sponsored abstracts, manuscripts, and publications related to the product
• Identifying and escalating strategic Data Science issues/challenges relevant to a program to key cross-functional teams/forums (CDT/MAPT) as well as to Data Science management for review, discussion, and mitigation planning

Clinical Development Focus:

• Participating in new drug development programs as a Subject Matter Expert (SME) in statistics area and providing statistical leadership in the design of clinical development plans
• Representing Biostatistics in meetings with regulatory agencies and preparing oral/written responses to agency questions, as needed
• Providing statistical leadership for preparation of marketing applications (e.g., NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies
• Supporting or leading filing efforts, as appropriate, including representing Biostatistics on the cross-functional filing team and contributing to filing strategy

Medical Affairs, RWE, and Market Access Focus:

• Providing statistical leadership for preparation and support of team interactions with regulatory/HTA agencies and HCPs
• Representing Biostatistics in meetings with regulatory/HTA agencies and preparing oral/written responses to agency questions, as needed
• Supporting or leading Biostatistics, Medical Affairs/RWE/Medical Access publication efforts, as appropriate, including representing Biostatistics on the cross-functional team and contributing to Medical Affairs/RWE/Medical Access publication strategy and plan
• Developing and maintaining current knowledge and understanding of competitive environment and BioMarin product positioning vs. competitors for relevant products through research and discussions with other stakeholders; sharing knowledge with team

Education:

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

Experience:

• 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.