Overview

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. 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.

Location: Preferable London, UK or San Rafael, CA, US (Remote / Flexible allowed dependent on candidate).

Summary

The Data Management Science (DMS) Operations Associate Director role is responsible 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

• 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 (CRF) in concise, self-explanatory, and user-friendly format. Collaborate with study team colleagues to ensure CRF 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-functional partners/stakeholders: Data Science colleagues, GSO, GMAF, CLS, BPV, Translational Science, Project Management, Compliance, and Regulatory
• Participate in Data Analysis and Review Team (DART), when appropriate, to discuss Data Management deliverables and activities

Subject Matter Expertise

• Participate in initiatives aimed at expanding Data Science and Data Management capability in areas such as Automation and Artificial Intelligence, CDISC/CDASH, central labs, local labs, ePro, imaging, RWE, etc. by building best practices in processes, tools, templates, or other guidance for the subject area

Competencies

Decision Making, Critical thinking and Problem Solving, such as skill in the ability to gather data and input, using multiple sources if applicable, to develop holistic understanding of problems and propose comprehensive solutions.

Influence, Cross-Functional Collaboration and Organizational Awareness, by seeking opportunities to interact with peers and stakeholders; builds a network of internal and external peers.

Agility and Proactivity, by being able to demonstrate resourcefulness to find, and resolve to be comprehensive in obtaining, information needed for complete and timely close out of tasks and deliverables.

Leadership, such as skill in clearly communicating objectives, goals, and expectations to others. Emerging understanding of study team roles and responsibilities and how they contribute to overall priorities; recognizes opportunities to improve study deliverables to support the organization.

Communication, including an ability respond promptly to stakeholders, peers, and management with clear and organized messages and ensures that important information is shared in a timely manner.

Strategic Thinking and Planning, such as an ability to focus on performance measurement to track progress toward objectives.

Operations, such as being able to demonstrate basic understanding of how programming supports study execution phases; ask questions and seeks guidance to clarify understanding and priorities. Experienced with clinical data programming and able to review and evaluate clinical data. Communicates design/specs in an unambiguous manner and adjusts communication as per the context.

General data management science skills, such as the development of comprehensive data validation plans in accordance with standards/SOPs; consistently approaches data validation and data quality planning with a focus on process improvement. Understands the objectives/purpose of each drug development phase (I-IV) and the related key cross-functional deliverables. Demonstrates basic knowledge of relevant products(s), the disease/condition that the product(s) treat, mechanism of action, efficacy, safety profile, and development status. Familiar with key medical coding terms and reporting formats; able to review and identify potential issues based on coding.

Career Development

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

People Management

The Associate Director role may manage 1 or more supporting consultants, in the context of completing study deliverables and/or departmental initiatives.

Education And Experience

• PhD or MA degree preferred; or BA/BS degree with a focus in data science, statistics, computer science, life science, or related scientific discipline
• 3+ years of experience in clinical development, including technical experience within and outside of Data Management Science, with PhD; or 5+ years with MS; or 8+ years with BS

Work Environment / 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 utilizing 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 Data Science and Data Management Science personnel.

Job Details

• Seniority level: Director
• Employment type: Full-time
• Job function: Manufacturing
• Industries: Biotechnology Research and Pharmaceutical Manufacturing