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.
1. Develops statistical analysis plans and reporting specifications for simple to complex clinical studies.
a. Develops and describes appropriate statistical techniques for the analysis of data in a statistical analysis plan.
b. Consults with other statisticians on statistical methodology, study design, therapeutic area details, and data analysis.
c. Works closely with analysis programmers and medical writers to design appropriate shells and specifications for outputs that can be produced efficiently.
d. In lead role on studies, reviews statistical analysis plan if written by others.
2. Performs statistical analyses and interprets results from simple to complex clinical studies.
a. Develops or QCs analysis programs to implement techniques described in the statistical analysis plan.
b. Approves final database for freeze/lock.
c. Assesses model assumptions for statistical analyses.
d. Performs senior review of analysis output.
e. Works with programmers, writers, and clinicians to coordinate data summarization and analysis activities, including summary statistics, tabulations, graphics, analysis output, and raw data listings.
f. Develops and reviews statistical reports, statistical sections of clinical study reports, and integrated statistical and clinical reports.
g. Performs senior review of statistical reports, statistical sections of clinical study reports, and integrated statistical and clinical reports.
3. Contributes statistical expertise to project teams for the design, analysis, and reporting of simple to complex clinical studies.
a. Serves as primary functional representative on project teams; may assume the role of project manager.
b. Provides significant input into the preparation and review of clinical study protocols; consults with clients on issues related to study design, statistical methodology, and sample size calculation.
c. Creates dummy and final randomization schemes for clinical studies.
d. Consults on the development and review of CRFs, data edit specifications, and critical variable lists.
e. Works with the project manager and functional manager to determine resource projections and project schedules.
f. Visits clients to discuss statistical issues.
g. Represents clients regarding statistical issues at regulatory meetings (simple studies only).
4. Maintains, develops, and shares knowledge of company and industry procedures and methodologies.
a. Performs billable work in accordance with PRA’s policies, procedures, and SOPs.
b. Maintains in-depth knowledge of drug development process.
c. Maintains in-depth knowledge of SAS procedures and good programming practices.
d. Continues statistical training on new methods and techniques via self-study, internal training and courses, and external conferences and courses.
e. Trains and mentors new or junior statisticians on statistical methods and PRA procedures.
f. Participates in sales activities, including bid defense meetings and preparation and review of estimates and proposals.
g. Develops in-depth knowledge of FDA and EMEA guidelines and requirements for reporting of clinical trials data.
PRA is an Equal Employment Opportunity / Affirmative Action Employer
· MS degree in Statistics or Biostatistics
· Demonstrated skills in multiple statistical and therapeutic areas
· Statistical experience in a pharmaceutical industry-related environment
· Demonstrated ability to plan, implement, and monitor the statistical processes for clinical studies
· Good communication skills with demonstrated leadership ability
PRA International - 19 months ago