Statistician

VALIDATION ASSOCIATES LLC•Bethesda, MD

5d•$55 - $60

About The Position

This role involves collaborating with clinical investigators, sponsors, and cross-functional teams to determine study design, develop statistical analysis plans, and perform statistical analyses for clinical research studies. The Statistician will also be responsible for generating reports, ensuring participant safety, and optimizing clinical site performance.

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

Responsibilities

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