Sr. Data Associate, Data Management Science

Sr. Data Associate, Data Management Science Overview

Bio Marin 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. Bio Marin aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative Bio Marin therapeutics, advancing the standard of care, and providing personalized support and services globally.

Bio Marin Global Data Science (GDS) is responsible for designing, capturing, analyzing, and presenting data that can drive key decisions for Clinical Development, Medical Affairs, and other business areas of Bio Marin. With a quality‑by‑design culture, GDS builds quality data that is fit‑for‑purpose to support statistically sound investigation of critical scientific questions. The GDS team develops solid analytics that are visually relevant and impactful in supporting key data‑driven decisions across Bio Marin.

The GDS Data Management Science (DMS) group contributes to Global Data Science by providing complete, correct, and consistent analyzable data at data, data structure and documentation levels following international standards and GCP. The GDS DMS Operations sub‑function is responsible for the efficient and effective delivery of complete, correct, and consistently fit‑for‑purpose data sets for statistical analysis across all clinical development and post‑approval programs.

The team brings a focus on process improvement through innovation and the application of best practices to the oversight and execution of all program‑related data management activities such as protocol review, case report form (eCRF) development, data management plan development, data validation plan development, requirement specifications, reconciliations, and data validation activities to ensure data integrity and data quality.

The Senior Data Associate supports the Clinical Program and acts as the GDS DMS Study Lead in the execution of assigned data management tasks.

The GDS DMS Operations Sr. Data Associate role is a Study Lead role. The Sr. Data Associate participates in all study‑related data management activities, including protocol review, eCRF development, data management plan development, data validation plan development, reconciliations, and the delivery of complete, correct, and consistently fit‑for‑purpose study datasets for statistical analysis.

The Sr. Data Associate may also act as a process improvement / departmental initiative contributor, as needed.

Sr. Data Associate may participate in all, or part of, the following activities as delegated by the GDS Data Management Science Operations Program Lead.

Program Planning and Execution:

• Draft Case Report Form (eCRF) in a concise, self‑explanatory, and user‑friendly format. Collaborate with study team colleagues to ensure eCRF completion guidelines/instruction are accurate.
• Draft Data Management Plan outlining key Data Management activities and deliverables.
• Collaborate with Clinical Programming and Data Quality Science and facilitate the completion of the Data Validation Plan.
• Conduct appropriate ongoing/periodic data validation activities, including reviews of data listings, discrepancies‑and related follow up on management of queries with investigators.
• Draft data transfer specifications.
• Conduct SAE reconciliation activities.
• Maintain data transfer calendar requirements.
• Post listings/reports/profiles to study file locations.
• Reconcile external data, including drafting data transfer specifications and header data.
• Maintain and track timeline, discrepancies, query resolution, and deliverable status.
• Track data flows and data review status.
• Maintain Trial Master File (eTMF) updates for all data management deliverables.

Subject Matter Expertise:

• Participate in initiatives aimed at expanding Global Data Science and Data Management Science…