Description

Primary Responsibilities:

• Responsible for protocol development including study design, sample size calculation,
  randomization, and statistical analysis plan for assigned studies.
• 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 regard to statistical methodology and provide appropriate
  training to less experienced statisticians.

Requirements

Candidate Profile:

• MSc or PhD in Statistics, Biostatistics or related field. PhD with 4-6 years of experience or MScwith 7-10 years of experience.
• Strong oral and written communication skills, with ability to communicate effectively internally and with clients.
• Demonstrated understanding and insight in statistics, drug development process and relevant FDA regulations.
• Pharmaceutical or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA.