Biogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.
The Data Management Team provides program and project oversight of outsourced clinical trials and is part of the Global Biometrics department, which consists of Data Management, Biostatistics and Statistical Programming. The Program Data and Analytics Lead ensures consistent application of Clinical Data Management operational decisions, data standards, and process within a program or group of studies.; recognized as an operational specialist in clinical data flow and study execution by all functions across Development Sciences. Partners with key study team members to facilitate implementation of a robust and clear data strategy plan for studies within assigned program. Uses program, phase, TA and operational knowledge to establish study level operational plans and works with DM leads at CROs and other vendors to ensure timely execution.
Develops program/study level quality plans to ensure alignment of study operational plans with program goals.
- Develops program timeline and monitors data deliverables for all studies within assigned program in collaboration with cross functional team members and vendors.
- Develops/Interprets and applies data strategy, verifies consistency and usage of data standards
- Coordinates and oversees outsourced personnel, and monitors and reports on overall study/program progress. Accountable for overall quality of study data.
- Develops risk mitigation or action plans and oversees execution when appropriate.
- Serves as a contact representing DM within Biometrics and clinical study management teams (SMT and/or Clinical Development Team representatives). Liaises directly with internal customers (Biometrics functions, GCO, Regulatory Affairs) and external customers (Full Service and Functional Service Provider Data Leads and Project Management personnel)
- Serves as Subject Matter Expert alongside Biometrics counterparts for data, reporting, and analysis process definition, improvement, and innovation as needed
- Manages performance and quality issues with vendors and escalates to vendor managers and Management and develops appropriate risk mitigation as needed
- Support study-level audit and inspection readiness activities as needed
- Serve as project manager on special projects and initiatives; partners with Statistical Programming, VM and Quality depending on type of project
- 10+ years relevant work experience with a focus on data management
- Deep understanding of drug development and biopharmaceutical industry required
- Strong project management skills, and ability to effectively lead and collaborate with various business functions project management certified desirable
- High attention to detail including proven ability to manage multiple, competing priorities
- Experience overseeing outsourced clinical trials work
- Demonstrated ability to establish effective business relationships with external stakeholders, including implementing process change at a vendor
- Deep knowledge of clinical data management outsourcing with full-service, global CROs and FSPs
- Expertise in clinical program indications, end points, dataflow, data integrity, standards, and data quality
- Demonstrated ability to influence without authority
- Excellent written and oral communication skills
- Bachelor’s degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
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