Sr. Manager, Statistical Programming

Job Details

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.

SUMMARY BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating, and have few, if any, treatment options. BioMarin aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative BioMarin therapeutics, advancing the standard of care and providing personalized support and services globally. BioMarin Data Science is responsible for designing, capturing, analyzing and presenting data that can drive key decisions for Clinical Development, Medical Affairs and other business areas of BioMarin. With a quality-by-design culture, Biometrics builds quality data that is fit for purpose to support statistically sound investigation of critical scientific questions. The Data Science team develops solid analytics that are visually relevant and impactful in supporting key data driven decisions across BioMarin. 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 statistical programming 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. The Senior Manager acts as a Study Lead within Data Analytics Science, carrying out statistical analysis programming plans for one or more assigned clinical studies according to relevant timelines and standards. They perform statistical analysis and produces data sets and TLGs in response to planned analyses, ad hoc queries, and information requests. In addition, the Study Lead manages Statistical Analysts and FSP consultants to develop and verify statistical programs and support execution of statistical analysis plan. This Senior Manager position is to support post-approval studies and the cross-functional secondary analyses. RESPONSIBILITIES Statistical programming deliverables and execution

• Work with Study Execution Team (SET) to plan the production and generation of datasets and tables, listings, and graphs (TLGs)
• Partner with Program Lead and other functions, Data Management Science, Statistical Science and Quantitative Science, to align on and create study deliverables, e.g., CRFs, Statistical Analysis Plan, etc.
• Lead study 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
• Participate in drug development study teams as a Subject Matter Expert (SME) in statistical programming
• Participate in planning for, and responses to, FDA and other HA interactions and queries
• Ensure processes and procedures are carried out in a compliant and consistent manner according to published guidelines for all assigned compounds
• Manage FSP programmer study activities and review FSP programmer deliverables
• Conduct program development and verification, identify bugs, and resolve technical problems
• Identify new tools to increase efficiency and quality
• Adhere to departmental procedures and practices, technical and industry standards, and programming concepts and conventions during all aspects of work

Cross-functional leadership

EDUCATION Master's degree (preferred) or BA / BS degree with a focus computer science, statistics, biostatistics, mathematics, or other related scientific discipline 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.