Associate Director, Data Management Science

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.

• Strategic Leadership: Ensure all activities and deliverables follow defined procedures and timelines. Lead improvements to existing processes and develop new methodologies to enhance efficiency and data quality.
• Conformance Programming Oversight: Oversee the development and maintenance of data conformance specifications and programming methodologies. Ensure consistency and support the design of novel conformance checks.
• Conformance Analysis Oversight: Direct conformance review activities, ensuring accurate identification and resolution of issues. Communicate conformance issues and risks to relevant stakeholders.
• Standards Development Oversight: Lead the development and maintenance of Data Transfer Standards and controlled terminology. Ensure version control and support root cause investigations.
• AI/Innovation Ownership: Evaluate emerging technologies and champion the use of AI to enhance processes and workflows.

• Technical Expertise: Proficiency in programming languages (Python, R, SAS), data validation, automation, and data standards (CDISC).
• Data Transfer & Integration: Expertise in configuring secure data transfer methods and familiarity with data management systems.
• Clinical Data & External Sources: Understanding of laboratory data, imaging, and device data.
• Technology & Innovation: Knowledge of cloud-based data platforms and emerging tools.
• Analytical & Problem-Solving Skills: Ability to investigate complex issues and propose solutions.
• Leadership & Strategy: Ability to set vision and direction for external data acquisition.

• PhD or MA degree preferred; or BA/BS degree in data science, statistics, computer science, life science, or related field.
• 3+ years of experience in clinical development with a PhD; or 5+ years with an MS; or 8+ years with a BS.

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.