Associate Director, Data Management Science

Biomarin; Camden Town; On-site; GBP 80,000 - 100,000; Full time

Job summary

A biopharmaceutical company in Camden Town is seeking a DMS Operations Associate Director. This role includes overseeing study-related data management activities, ensuring data quality, and collaborating across departments. The ideal candidate has a strong background in clinical development and data management, with a PhD or equivalent experience. This position offers a unique opportunity to impact patient outcomes through innovative data-driven decisions.

Qualifications

• 3+ years of experience in clinical development for PhD holders, 5+ years for MS, or 8+ years for BS.
• Experience within and outside of Data Management Science.

Responsibilities

• Oversee all study Data Management activities.
• Conduct protocol review and raise data collection considerations.
• Develop Data Management Plans and ensure compliance with guidelines.
• Collaborate with clinical programming to address data issues.

Skills

Subject Matter Expertise in Data Management

Critical Thinking and Problem Solving

Cross-Functional Collaboration

Agility and Proactivity

Effective Communication

Leadership Skills

Strategic Thinking

General Data Management Skills

Education

PhD or MA degree in relevant fields

BA/BS degree in data science or related fields

Job description

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. The Data Management Science (DMS) group contributes to Data Science by providing complete, correct, and consistent analyzable data at data, data structure and documentation levels following international standards and GCP. The 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 quality validation activities.

The 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.

Responsibilities

• 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.
• 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)).
• 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.
• 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.

Skills and Competencies

• Subject Matter Expertise: Participate in initiatives aimed at expanding Data Science and Data Management capability in a designated area of expertise, 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.
• Decision Making, Critical Thinking and Problem Solving: skill in gathering 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: seek opportunities to interact with peers and stakeholders; build a network of internal and external peers.
• Agility and Proactivity: demonstrate resourcefulness to find and resolve information needed for complete and timely close‑out of tasks and deliverables.
• Leadership: 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; recognize opportunities to improve study deliverables to support the organization.
• Communication: ability to respond promptly to stakeholders, peers, and management with clear and organized messages and ensure that important information is shared in a timely manner.
• Strategic Thinking and Planning: focus on performance measurement to track progress toward objectives.
• Operations: demonstrate basic understanding of how programming supports study execution phases; ask questions and seek guidance to clarify understanding and priorities.
• General data management science skills: development of comprehensive data validation plans in accordance with standards/SOPs; consistently approach data validation and data quality planning with a focus on process improvement.
• Understand objectives/purpose of each drug development phase (I‑IV) and related key cross‑functional deliverables.
• Basic knowledge of relevant products, 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.

Qualifications

• 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 / 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 utilizing common business software programs and hardware solutions.