Sr. Data Associate, Data Management Science

Overview

Sr. Data Associate, Data Management Science

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.

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 BioMarin. 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 delivery of complete, correct, and consistently fit-for-purpose data sets for statistical analysis across all clinical development and post-approval programs. The team focuses 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.

Key Responsibilities

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

• 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 the 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
• Participate in initiatives aimed at expanding Global Data Science and Data Management Science capability in a designated area of expertise, such as CDISC / CDASH, central labs, local labs, Artificial Intelligence (AI), ePRO, imaging, RWE, Risked Based Quality Management (RBQM), etc. by building best practices in processes, tools, templates, or other guidance for the subject area

Competencies

Career Development

BioMarin offers comprehensive career development programming, including guidance, targeted training opportunities, and mentorship programming. A career development pathway for GDS Data Management Science has been defined and is available to employees of BioMarin.

People Management

The Sr. Data Associate will be an individual contributor. This position will contribute to and make an impact on project or study team outputs.

Education and Experience

Work Environment / Physical Demands / Travel

The employee may frequently be required to sit and talk or listen. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and / or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

Equipment

Computer work utilizes common business software programs and hardware solutions.

Contacts

This position will interact with a range of personnel across the BioMarin organization, including but not limited to other Global Data Science and Data Management Science personnel.

The salary range for this position is : $null to $95000.00. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. For additional benefits information, consult the BioMarin careers site for details.

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