A Leading CRO has an opening for a Permanent, full time position as a Principal Biostatistician.
Job Title: Principal Biostatistician
Employment Type: Full Time
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
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 explore alternative analysis strategies as needed.
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.
Effectively mentor peers with regards to statistical methodology and provide appropriate training to
less experienced statisticians.
Manage activities of statisticians across projects by appropriately coordinating assignments and
reviewing work so that projects are delivered on time with high quality.
MS or PhD in Statistics, Biostatistics or related field. PhD with 3-5 years of experience or MS with 6-8
years of experience.
Strong oral and written communication skills, with ability to communicate effectively internally and with
Demonstrated understanding and insight in statistics, drug development process and relevant FDA
Pharmaceutical or related industry experience with clinical trials, including interaction with Regulatory
Agencies, especially FDA.