Provide statistical leadership for the development of Biosimilars including strategic input into the clinical development plan.
Act as PLS internally (e.g. CDTs) and externally (e.g. in interactions with regulatory agencies and health care professionals).
Subject matter expert for all statistical questions.
Ensures statistical integrity, adequacy, and accuracy of the clinical studies defined in the clinical development plan (CDP).
Ensures optimal Biostatistics support for regulatory submissions.
Supervision of involved CROs for all statistical aspects.
Collaborate effectively with internal cross-functional teams and external partners (e.g. joint development partner).
Collaborate effectively with all Biostatistics, Statistical Programming and Data Management colleagues within MDSA.
Contribute to the internal operating and governance model for the conduct of Biosimilars trials, and to foster and implement best practices across projects.
Represent Biogen in cross-company initiatives regarding the development of Biosimilars.
MS or PhD in Biostatistics, Epidemiology or equivalent, and a MS with 5-7 years or a PhD with 3-5 years of drug development experience acquired at pharmaceutical companies or CROs.
Very good understanding of theoretical and applied statistics (including but not limited to Estimands, missing data and (bio)-equivalence trials).
Strong understanding of drug development with proven ability to identify and deliver key evidence needed for clinical development. Biosimilar experience is a plus.
Experience with authorities (FDA and EMA) in the context of regulatory approvals.
Excellent knowledge of with ICH and other relevant guidelines (e.g. FDA, EMA and NMPA).
Programming experience with R, SAS, or other statistical software packages (e.g. EAST).
Advanced understanding of CDISC (SDTM and ADaM).
Ability to work independently.
Fluent in English
Highly motivated and enjoying working in cross-functional teams (e.g. CDT).
Demonstrate strong organizational skills, including the ability to prioritize workload.
Excellent written and verbal communication skills.
We have an exciting new opportunity for a Senior Principal Biostatistician to join our Biosimilars team in Europe. You will be part of the Medical Data Science and Analytics (MDSA) Biosimilars team. As a Project Lead Statistician (PLS), you will represent MDSA in the clinical development team (CDT). You will be responsible for all statistical aspects in the development of a biosimilar from pre-clinical activities to regulatory submission/ approval and post approval activities.