Associate Director, Data Management Science

**ASSOCIATE DIRECTOR**,**Data Management Science**

**Job Title**:
Associate Director, Data Management Science

**Department / Cost Center**:
Data Management Science / cc256

**Reports to (Job Title)**:
Director, Data Management Science

**Job Code**:
**Location**:
Preferable London, UK _or_ San Rafael, CA, US

**Date Prepared**:
AUG-2025

**Full-Time**Part-Time**

**Regular**Temporary**

**Exempt**Non-Exempt**

**OVERVIEW**:Data Science, Data Management Science (DMS)**

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, Data Science 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.

**SUMMARY DESCRIPTION**

The DMS Operations Associate Director role is responsible for all for 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 data sets for statistical analysis.

The Associate Director may also act as Process Improvement / Departmental Initiative Lead, as needed.

**KEY RESPONSIBILITIES**:

- DMS _Operations _Associate Director_ may perform a range of the following responsibilities, depending upon the _studies’_ complexity and _studies’_ development stage: _

**_Program Planning and Execution:_**
- Complete all study Data Management activities and deliverables, including (but not limited to):

- Ensure Data Management colleagues and Data Science colleagues are engaged in study startup activities by facilitating appropriate project management activities, such as kick off meetings, timelines, other relevant communications
- Conduct protocol review and raise any data collection considerations affecting data quality, reliability, or suitability for statistical analysis
- Define Case Report Form (eCRF) in concise, self-explanatory, and user-friendly format. Collaborate with study team colleagues to ensure eCRF completion guidelines/instruction are accurate
- Develop and facilitate approval of 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
- Collaborate with Clinical Programming and Database Development colleagues to ensure that database build occurs in accordance with specifications and timelines
- Execute appropriate ongoing/periodic Data Validation activities in collaboration with Clinical Programming, including reviews of data listings, discrepancies, and the related follow-up on management of queries with investigators
- Conduct the identification, investigation, and resolution and/or escalation of study and program data issues, as appropriate
- Oversee and facilitate medical coding activities
- Collaborate with Clinical Programming on the development and execution of data transfer specifications
- Collaborate with Clinical Programming and BioMarin Pharmacovigilance (BPV) on SAE reconciliation activities
- Complete pre-database lock or snapshot checklist activities and related Data Validation meetings with cross-functional stakeholder to approve the DB lock/snapshot go ahead
- Develop and deliver regular updates to leadership on key program risks, issues, and milestones
- Oversee Trial Master File update for all Data Management deliverables
- Ensure compliance with Regulatory Guidelines (e.g., FDA, ICH) across all study-related DMS activities

**_ Cross-Functional Leadership_**
- May represent Data Management as a member of the relevant study team (e.g., clinical Study Execution Team (SET) or post-approval Medical Affairs Program Team (MAPT) or Study Team (MAST)
- May lead a Data Working Group to investigate, diagnose, and resolve study data issues; lead the cross-functional review of data management deliverables: CRF, edits checks, DM plan
- May lead all data collection and management-focused meetings with cross-functio