Associate Director, Data Analytics Science

Location:  San Rafael, California Category: Data Science

Hiring Manager: Annie Chang ([email protected]), Erika Liu ([email protected])

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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.

The Data Analytics Science team is responsible for providing statistical application development leadership, oversight for data standards, and programming analysis across all molecules. The team is responsible for leading Data Analytics Science execution for all phases of clinical trials and drug development, including regulatory submissions. The Data Analytics Science sub-function develops validated statistical programs for generating analysis datasets and evidence reports (TLGs) and implements and utilizes statistical models to analyze and solve scientific problems in support of submission and new drug development.
 
About the Opportunity:
The Associate Director will provide statistical programming leadership and oversight for clinical trials, including regulatory submissions, and statistical application development. This individual is also responsible for production of statistical programming deliverables, either personally, or by directing and coordinating activities of others, or by supervising programming managers, programmers, and partnering with vendors and third parties as applicable.
 
 
Responsibilities include:
 
·         Lead project programming team to develop datasets (ADaM) and TLGs for clinical study reports, submissions (NDA/BLA) to worldwide regulatory agencies (e.g., FDA, EMA), publications, ad hoc and other statistical analysis requests; carry out integrated analysis if assigned.
  • Builds effective working relationships with cross functional groups within Data Science and across BioMarin to ensure that customer/stakeholder needs are met
·         Ensure processes and procedures are carried out in a compliant and consistent manner according to published guidelines for all assigned compounds.
  • Effectively utilizes assigned resources as necessary and manages deliverables completion to meet project timelines
·         Manage CRO and FSP programmers study activities and review programming related deliverables
·         Conduct program development and verification, identify bugs, and resolve technical problems
·         Identify new tools to increase efficiency and quality
  • Adheres to and responsible for monitoring compliance with departmental procedures and practices, technical and industry standards and programming concepts and conventions during all aspects of work
  • Investigates trends, identifies techniques and makes recommendations for new methods and technologies used in pharmaceutical and/or biotech industries for reporting and managing clinical data

 

 
Leadership Responsibility:
  • Provide leadership for departmental strategic initiatives and process improvement.
  • Guide career growth and provide development opportunities for analysts and programmers.
  • Monitor project progress and ensure proper resource allocation for successful project deliverables against goals and timelines.
  • Managing and reviewing contractors’ deliverables as necessary
 
Must have: Minimum Requirements:
  • Master’s degree (preferred) or BA/BS degree with a focus on computer science, statistics, biostatistics, mathematics, or other related scientific discipline.
  • 12 or more years of clinical trial experience, statistical programming, and/or drug development experience with BA/BS; 10+ years with Master’s.
  • Good knowledge of CDISC standards and programming in SAS
  • Experience with Regulatory submissions
  • Managing others including managers of statistical programmers

 

 
 
Nice to have:
  • Master’s degree in computer science, statistics, biostatistics, mathematics, or other related scientific discipline
  • Experience with programming in R or Python



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.

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