What are the responsibilities and job description for the Statistician position at Technical Resources International, Inc.?
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.
- PhD in biostatistics, statistics, epidemiology or related field.
- 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.