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

The Senior CDM (Clinical Data Management) Applications Analyst is responsible for developing EDC database, contributing to the assessment and tracking of quality of programming tasks and activities executed by CRO and FSP vendors performing clinical trial programming work for Biogen.  The position collaborates with the DM staff, management, and vendor clinical programmers to schedule and conduct the review of study documentation, build EDC database and edit checks, custom functions and perform programming quality checks and technical review related to the design and testing of EDC databases, to ensure that all clinical trial databases and electronic collection tools are consistent with the needs of the study protocol and department standards and procedures. 

What You’ll Do

• Participates in activities as related to building study databases and applies competent knowledge of the programming of moderate CRF design, database building, edit checks,  Custom function programming, system interfaces and all system feature configurations.
• Provides input to Trial Data Manager to define study specific database design within the CDMS system (i.e Medidata Rave), performs clinical database programming activities on multiple studies of simple to moderately complex design and expert in all areas for relevant CDMS.
• Perform User Administration activities for Rave EDC, Coder & EOS Media portal.
• Serves on project teams to coordinate and lead CDMS activities for clinical database programming projects
• Attends sponsor audits and assists with in-progress audits, including presenting the CDMS process and procedures and presenting the validation documentation produced by the validation group.
• Conducts peer review and Technical review of clinical programming deliverables from internal and vendor employees
• Performs additional clinical programming tasks including but not limited to data loading, generation of metrics and report creation.

Who You Are

Pragmatic and willing to drive and support change. Embody a culture of continual improvement and innovation; promote knowledge sharing.

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.

Required Skills

• Bachelor’s degree specialization in Computer Science, Information Science, Life Sciences, Clinical Data Management, or Drug Development preferred
• 3+ years Clinical Database programming experience working in the biotechnology or pharmaceutical industry; experience working with CROs highly desirable
• Technical/Software Skills: Expertise with Medidata RAVE (Custom Function programming) required. PhaseForward Inform, Oracle Clinical and/or other clinical data management software desirable;
• Experience applying best practices in clinical data management programming in the clinical trial environment, including requirements definition and QC plans
• Knowledge of GCP and other regulations.
• Internal customer management, influence of peers, team effectiveness and enhancement, timeline management, proactive problem-solving ability, ability to develop trust, shared goals and values.

*Applicants must reside in the United States

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.