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.

• Ensure credible internal and external communication of clinical and post approval trial data.  Ensure data interpretation from BioMarin-sponsored clinical trials are accurate, scientifically sound, and credible.  
• Represent BioMarin as the senior statistical executive for Health Authorities (e.g., FDA, EMA, etc.) and participate in regulatory meetings and interactions with Health Authorities as needed or requested.   
• Establish close and effective collaborative relationships with drug development teams and other leaders and key stakeholders in WWRD to maximize insights in acquiring and interpreting data as we develop products together.  
• Translate development strategies into tactical plans to support product development objectives. Provide expertise and guidance in clinical study design and institute best practices regarding planning, execution, and interpretation of clinical projects and studies.  
• Establish or refine standards for information systems used within Data Science considering company policies, practices, and operating procedures compliant with industry standards.    
• Assure adherence to all aspects of the GCP, data integrity, & business ethics requirements.  
• Optimize organizational structure to meet current programs and product objectives; effectively assign staff to support achievement of corporate and WWRD goals and objectives and support key activities. Lead recruiting activities for the department.  
• Proactively assess effectiveness of systems and processes and promote continuous improvement and innovation.  
• Oversee the development of standard operating procedures for clinical trials; ensure that all personnel appropriately interpret and follow procedures.   
• Serve as Senior Reviewer for reports that summarize the analysis of data, interpret findings and provide conclusions and recommendations. Represent Data Science on cross-functional review committees such as PRC, CRC, PSC.  
• Provide leadership beyond Data Science as required.   

• Minimum of 15 years’ experience in providing support within the pharmaceutical/biotechnology industry that includes early and late-stage development.  
• Minimum of 5 years’ experience leading and managing Biometrics/Data Science   
• Expert knowledge of best practices and thorough understanding of global regulations and guidelines.  
• Demonstrated ability to operate effectively and achieve results in a dynamic, matrix organization as part of a working team environment, with the ability to provide both strategic leadership on safety issues and tactical input.  
• Must be able to operate at a broad level to support business goals while overseeing execution of details.  
• Demonstrated ability to form effective working partnerships with colleagues, subordinates and external counterparts, as well as experience supervising personnel, budgeting, organizing, and planning for a growing department.  
• Excellent organizational skills, with ability to guide multiple projects of varying complexity.  
• Proven track record of utilizing sound project management skills including setting goals and milestones and managing activities to meet business needs.  
• Demonstrated deep understanding of cross-functional elements of drug development. Prior experience in managing other functions within Clinical Development or Medical Affairs is considered an advantage.  

• PhD degree in Statistics or equivalent with required experience.  
• High-integrity professional with sound judgment and decision-making ability.  
• Ability to lead innovation and change.  
• Strategic agility and critical thinker.  
• Effective communicator with strong verbal and written skills.  
• Ability to motivate and inspire a commitment to excellence and develop others.  
• Effective collaborator and team player with ability to align people.  

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.