Principal Statistician

Houston, Texas

Welcome to Join Our Growing Team!

We are looking for a Principal Statistician to join our team in Piscataway, NJ. The primary role of the Principal Statistician is to perform statistical programming, data management, and data analysis under the direction of Biostatistics faculty members to fulfill our commitment to the research projects. Also responsible for the activities of junior statisticians and programmers working on the assigned program of studies, ensuring studies are delivered on time, on budget, and to required quality.

What The Job Entails:

  • Responsible for protocol development/Review 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 explore alternative analysis strategies as needed.
  • 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 regard 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.
  • Master's degree or PhD in Statistics, Biostatistics or related field, PhD with 3 - 5 years or Master Degree with 6-8 years of pharmaceutical or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA
  • SAS and/or R statistical programming skills.
  • Demonstrated understanding and insight in statistics, drug development process and relevant FDA regulations.
  • Demonstrated ability to identify areas of statistical research in improving the design, analysis and reporting of clinical study.
  • Strong oral and written communication skills, with ability to communicate effectively internally and with clients.
  • Demonstrated capability to effectively manage multiple projects.

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