My client is a public Pharmaceutical company in RTP, NC.
Associate Director, Biostatistics provides expert biostatistics support for the planning, design, conduct, analysis and reporting of clinical studies, as well as general statistical support for R&D and other departments.
include the statistical design of Phase I - IV clinical studies (specification of study hypotheses, sample size estimation and power calculations), the statistical delineation of study endpoints, writing statistical sections of clinical trial protocols and developing, reviewing and finalizing statistical analysis plans (SAP) to be used for the programming, analysis and reporting of study data.
The Associate Director will also develop SAPs in support of Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE) and perform detailed statistical review of all statistical deliverables, including analysis tables, listings and figures (TLFs).
In addition, the Associate Director will work closely with statistical programmers and external vendors to develop and implement specifications for the programming of statistical outputs and analyses.
The position requires a PhD Biostatistics or Applied Statistics minimum of 3-5 years of biostatistics experience in a clinical trials environment. Strong interpersonal, teamwork, and organizational skills are essential. Infrequent travel required for meetings with service providers, partners and the FDA will be required.