Principal, Clinical Data Reviewer
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.Job Description
About This Role
The main objective of the Principal Clinical Data Reviewer is to provide insights to ensure clinical data is scientifically plausible and to identify trends, signals and risks associated to trial endpoints and patient safety. You will provide clinical and scientific data review through all phases of a clinical study, working across multiple studies. You are accountable for the design and development of the detailed specifications of the study level listings for which you will be responsible to review. With guidance from a Senior Principal Clinical Data Reviewer or Manager and the Principal Clinical Data Lead, you will effectively manage project timelines and quality.
What You’ll Do
- Conduct ongoing clinical and scientific data review throughout the life of assigned clinical trial.
- Support the Clinical Data Management (CDM) team in defining, initial set-up, testing, and documentation of the clinical and scientific data review to be performed per study.
- Provide reports, status updates, feedback, and advice to key stakeholders throughout the life of assigned clinical trial/program.
Who You Are
You love clinical data and are passionate about using data to drive key business decisions to improve the lives of the patients we serve. You love learning new technological skills and working through collaboration.Qualifications
- Ability to prioritize multiple competing tasks and timelines across multiple studies/programs
- Ability to summarize clinical and safety trends identified during clinical data review
- Ability to understand/learn the clinical details of a therapeutic area in order to apply this knowledge to your review of the data
- 5 + years clinical operations or data management operations experience
- 5+ years pharmaceutical, biotechnology or CRO industry experience
- 3+ years of experience with Medidata Rave and a data review tool
- Experience with at least one Biogen therapeutic area
- Bachelors degree preferred
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.