Statistician

Job Description Collaborating with clinical investigators, sponsor, and cross-functional teams to determine study design; Collaborating with Medical Writing and Project Management teams on protocol development, including writing sections pertaining to statistical input; Development of statistical analysis plans and programs to perform analyses and display study data; Reviewing protocols and case report forms to ensure that protocol objectives are met and standards are maintained; Generating treatment allocations in randomized clinical research studies and ensuring proper implementation; Performing statistical analyses; writing and validating application programs, including for centralized monitoring purposes; Implementing data and safety monitoring reports to ensure participants’ safety; Developing metrics and generating quality control reports to optimize the performance of clinical sites and the coordinating center; Generating study reports to be distributed to internal and external monitoring committees and regulatory bodies; Participating in professional development activities both within and outside the company; Other duties as assigned. Requirements Minimum of 3-5 years of experience in a CRO environment; Demonstrated proficiency with statistical methods and applications in clinical research. Strong programming skills in SAS and/or R. Ability to manage multiple tasks. Ability to work independently, as well as in a team environment. Ability to effectively communicate technical concepts, both written and oral. #J-18808-Ljbffr VALIDATION ASSOCIATES LLC