Clinchoice-posted 10 months ago
Senior
Remote • New York, NY
Administrative and Support Services

ClinChoice is searching for a Senior/Principal Biostatistician Consultant to join one of our clients. This is a client-facing role, and we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client's counterparts. The position involves working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring.

  • 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.
  • Ensure 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.
  • Ensure validity of analysis and explore alternative analysis strategies as needed.
  • Demonstrate extensive understanding of statistical concepts and methodologies.
  • Recognize and correct flaws in scientific reasoning and statistical interpretation.
  • Ensure accuracy and consistency of statistical tables, figures, and data listings.
  • Ensure 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.
  • Identify and correct common flaws in interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assure 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.
  • 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 experience with Oncology TA.
  • Strong oral and written communications skills.
  • Demonstrated understanding and insight in statistics, drug development process and relevant FDA regulations.
  • Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA.
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