AD/Sr. Manager - Data Strategy & Design (Data Analytic Sciences)
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development 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 rare diseases. Come join our team and make a meaningful impact on patients’ lives.
The position will lead upcoming new GCD Projects and build up BMRN submission data standards.
- Build up BMRN Control Terminology (CT) database, including processes and utilities to meet compliance to CDISC standards. The CT database is an essential component of establishing data lake, a key element in the transformation of Data Analytics Science.
- Set up standard process on lab data conversions, including CT and lab units for the purpose of improving the data quality.
- Standardize pre-clinical data (CDISC SEND) and genomic data for submissions and data storage.
- Liaise and collaborate with CDISC and submit new CT terms to CDISC for approval.
- Lead clinical projects to create SDTM data files and prepare submission packages.
- BS in Mathematics, Statistics/Biostatistics, Computer Science, Data Science, or related applicable field. MBA or MS preferred.
Preferred Experience and Skills
- 10+ year of experience in quantitative data analysis with applied analytic experience.
- Experience in pharmaceutical industry, life sciences or healthcare data; Solid knowledge of industry standard like CDISC strongly preferred.
- Hand on experience on SDTM/ADaM programming and regulatory submission.
- Proficient with applied statistics, data analysis and visualization tools (e.g. SAS, R, Python, etc.).
May have responsibilities of direct line reporting of others. Also need to manage and monitor contractor/FSP, assign or direct the programming tasks of others on team.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.