Biogen Idec Research Triangle Park , NC 27709
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.
Thorough understanding of statistical principles and clinical trial methodology with the ability to practice and implement them.
Ability to provide technical solutions to a wide range of difficult problems. Solutions are innovative, thorough and practicable, and consistent with objectives.
Working knowledge of medical/biological terminology and clinical trial designs and competitive landscape in relevant therapeutic areas.
Able to write and present information effectively.
Conversant with SAS programming, and detailed knowledge of SAS procedures and/or other statistical software.
Working knowledge of regulatory guidelines/Worldwide Medical/Commercial needs relating to statistical analysis, study reports and statistical components of regulatory submissions.
Demonstrates leadership and communication skills
PhD in Biostatistics/Statistics or equivalent with a minimum of 4 years relevant work experience is ideal. Would consider MS in Biostatistics/Statistics with a minimum of 6 years relevant experience.