The Principal Biostatistician will serve as study statistician or support statistician on Bronchiectasis or Hepatitis B programs. TA experience is an advantage but not essential.
Primary Responsibilities:
- Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
- Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
- Responsible for assuring that data for statistical analyses are complete, accurate and consistent.
- Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.
- Responsible for validity of analysis and alternative analysis strategies when unforeseen circumstances arise.
- Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.
- Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings.
- Responsible for statistical methods section for the reports. Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assures project-wide consistency.
Qualifications
- MS or PhD in Statistics, Biostatistics or related field.
Mandatory Required Skills
- High degree of technical competence
- Understanding of Poisson regression or negative binomial methods, time to event, or multiple imputation methods
- Competent in experimental design, descriptive and inferential statistics.
- Pharmaceutical or related industry experience with clinical trials.
- Excellent communication skills, both oral and written.
- Excellent programming skills (SAS/R)