Sr. Principal Biostatistician
Biogen
Company Description
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 were 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
As the Senior Principal Biostatistician, you are responsible for leading study design and data analysis and providing the statistical expertise for company products within one or more therapeutic areas in clinical development, biomarker development, research, Biotherapeutic and Medicinal Sciences (BTMS) or Pharmaceutical Operations & Technology (PO&T). You act as independent Study Management Team (SMT) or Research and Development Project Team (RDPT) Biostatistician, provide statistical input in the scientific discussion, participate in protocol development, analysis plans and file/report specifications, and review study setup activities including but not limited to randomization, Case Report Forms (CRFs) and serve as lead biostatistician assigned project(s). You perform statistical analyses, interpret statistical results, and prepare clinical study reports including integrated summaries for submissions as appropriate. You also assist in preparation of responses to statistical issues arising in regulatory or other legal settings, or from external development partners. You maintain liaison with clinical research personnel in order to identify and meet the statistical support required by the development strategy under the supervision of the Associate Director or Director. You also contribute to the long-term growth strategy of the department by participating in process improvement initiatives, keeping abreast of the current statistical methodology development, and providing mentorship to new/junior biostatisticians.
What you’ll do
Represent Biostatistics on Project or Study Teams; provides statistical expertise to support clin
Cambridge, MA