Associate Director, Clinical Data Governance/Stewardship

At Biogen, we offer a workplace that is unique, connected, resilient and impactful. Our purpose to find cures for rare diseases is a unique focus within our industry. We are connected as a team by this shared purpose, the pride we have in our work, and the inspiration we obtain from the lives we’re changing. We are resilient as we overcome obstacles, following the science to deliver for our patients. Most of all, our work allows us to have an impact. An impact on our patients’ lives and on changing the course of medicine.

About This Role

As the Associate Director, Clinical Data Stewardship, you will maximize the value of clinical data through implementation of sustainable process. You will provide expertise, leadership for the implementation of clinical data stewardship activities across the department (Analytics and Data Sciences). You will act as an expert on best clinical data lifecycle management and governance processes (e.g. data access, sharing, retention). You will also work broadly across the department to create, implement, and improve processes in line with data stewardship strategy. Additionally, you will lead complex projects with little oversight leveraging your own deep expertise and your ability to collaborate with subject matter experts.

What You’ll Do

• Translate strategy into execution; roadmap and run projects maximizing the reusability, protection, and management of Biogen’s clinical trial data
• Collaborate with Clinical Data Management, Statistical Programming, Biostatistics, Analytics and Data Sciences (ADS) leadership to develop and implement solutions sustaining processes related to data lifecycle (Create, Store, Access, Use, Share, Archive, Delete)
• Act as a Data Stewardship expert (e.g. General Data Protection Regulation (GDPR), Good Clinical Practice (GCP) Data Integrity, Best data management practices, Best data governance/ data protection practices)
• Influence and collaborate beyond the department. Work to define a Research and Development (R&D) data stewardship model. Co-lead the Biogen Data Stewardship Community of Practice.
• Stay current with the latest in Data Governance, Data Stewardship, and FAIR (Findable, Accessible, Interoperable, and Reusable) data practices across the industry. Participate in industry working groups

Who You Are

You are a Clinical Data Steward who loves translating strategy into action. You have an eye for detail, hands on experience with clinical data and pertinent regulations and laws.

Required skills:

• Bachelor’s degree
• 10 years’ experience in a data related field (e.g. data science, library science, data governance) or in a clinical data field (e.g. Clinical Data Management, Biostatistics, Statistical Programming) Expertise in global industry regulations and best practices (E.g. Data Integrity, GCP, GDPR, FAIR)
• Experience with privacy regulations and data protection and data protection requirements
• Internal customer management, influence of peers
• Demonstrated ability to translate strategy into action
• Ability to develop trust, shared goals and values while working across cross-functional teams.
• Collaborative, with negotiation skills,
• Accountability to deliverables milestones, conflict resolution (internal and external)

Preferred skills:

• Experience with clinical trial data, deep understanding of clinical data and data processes
• Experience implementing FAIR
• Data governance experience (implementing data governance activities

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

All your information will be kept confidential according to EEO guidelines.