Pharmaceutical Research Associates, Inc.
(All) | US-RemoteOverview
Plays a functional lead role in the design, analysis, and reporting of clinical studies. Writes statistical analysis plans, performs statistical analyses, contributes to and reviews study reports, and interacts with other study team members and clients on study set up and conduct, including timelines and financial oversight.Responsibilities
- Develops statistical analysis plans and reporting specifications for simple clinical studies.
- Develops and describes appropriate statistical techniques for the analysis of data in a statistical analysis plan.
- Takes direction from other statisticians on statistical methodology, study design, therapeutic area details, and data analysis.
- Works closely with analysis programmers and medical writers to design appropriate shells and specifications for outputs that can be produced efficiently.
- In lead role on studies, reviews statistical analysis plan if written by others.
- Performs statistical analyses and interprets results from simple clinical studies.
- Develops or QCs analysis programs to implement techniques described in the statistical analysis plan.
- May approve final database for freeze/lock.
- Assesses model assumptions for statistical analyses.
- Works with programmers, writers, and clinicians to coordinate data summarization and analysis activities, including summary statistics, tabulations, graphics, analysis output, and raw data listings.
- Reviews statistical reports and statistical sections of clinical study reports.
- Contributes statistical expertise to project teams for the design, analysis, and reporting of simple clinical studies.
- Serves as primary functional representative on project teams.
- May participate in the development and review of CRFs, data edit specifications, and critical variable lists.
- Works with the project manager and functional manager to determine resource projections and project schedules.
- Visits clients to discuss statistical issues.
- Maintains and develops knowledge of company and industry procedures and methodologies.
- Performs billable work in accordance with PRA's policies, procedures, and SOPs.
- Maintains basic knowledge of drug development process.
- Maintains basic knowledge of SAS procedures and good programming practices
- Continues statistical training on new methods and techniques via self-study, internal training and courses, and external conferences and courses.
- Develops awareness of FDA and EMEA guidelines and requirements for reporting of clinical trials data
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
- MS degree in Statistics or Biostatistics.
- 3 to 5 years Clinical Biostat exp
- Awareness of multiple statistical and therapeutic areas.
- Ability to plan, implement, and monitor the statistical processes for a clinical study.
- Good communication skills with leadership potential.
- Must be able to commute to Whippany office daily.