Statistical Programmer

4 weeks ago

Rahway, United States Katalyst Healthcares and Life Sciences Full time
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 explore alternative analysis strategies as needed.
Qualifications:
  • 4+ years' experience preferred leading late phase studies.
  • MS or PhD in Statistics, Biostatistics or related field. PhD with 3-5 years of experience or MS with 6-8 years of experience.
  • Must have experience in Oncology & AdAM.
  • Strong oral and written communications skills, with ability to effectively communicate internally and with clients.
  • Infectious disease background + experience working on observational studies
  • Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA.

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