Principal Biostatistician

The Principal Biostatistician is responsible for providing project leadership in Biostatistics for one or more specific company products or a therapeutic area as assigned. He/She participates in the development of standards across protocols in protocol development, analysis plans and file/report specifications. He/She also reviews study setup activities including but not limited to randomization, CRFs and data edits and serves as lead biostatistician on one or more projects. This person performs statistical analyses, interprets statistical results, and prepares clinical study reports including integrated summaries for submissions. He/She reviews analysis of other study statisticians participating on their project for accuracy, consistency, and quality output. He/She also addresses regulatory issues and/or issues from external development partners. This person will act as Biostats SMT statistician and able to act as CDT statistician under supervision. Successful candidate will:

• Handle a moderate or large volume of complex tasks with minimal supervision. Should be able to manage work in one or more drug program(s).
• Proactively assess problems and adapt solutions for the Biometrics department. Will contribute to resolution of technical issues.
• Must be able to make decisions at study level across a variety of studies. Ability to lead and prioritize tasks and deliver on expectations on a global scale.
• Interact closely with clinical research, regulatory affairs, CROs, Commercial, Worldwide Medical, KOL's and collaborators from different disciplines across the organization by monitoring their needs and determining resources in consultation with their line managers.
• Participate/lead in organization-wide led initiatives e.g. Quality, standardization etc.
• Broad and thorough understanding of statistical principles and clinical trial methodology, and the ability to practice and implement them
• Ability to develop innovative/creative statistical/technical solutions to complex problems
• Knowledge and exp

Our Biostatisticians are responsible for providing the statistical expertise for products within a therapeutic area, including response to statistical issues arising in regulatory, commercial, worldwide medical or other legal settings, and may include addressing issues from external development partners and internal cross-functional project teams.