Biostatistician II

The Biostatistician II is responsible for statistical analysis and interpretation of clinical trial data. A solid foundation in statistical methodologies, experience in the pharmaceutical or clinical research industry, and the ability to collaborate effectively with cross-functional teams is required for the successful performance of this job.

What You'll Do:

• Statistical Analysis:
  * Perform statistical analyses for clinical trials, including the development and implementation of statistical analysis plans (SAP).
  * Generate tables, listings, and figures (TLF) to support clinical study reports, regulatory submissions, and data reviews.
• Data Review and Quality Control:
  * Conduct comprehensive data reviews to ensure the accuracy and integrity of clinical trial data.
  * Collaborate with data management teams to address data discrepancies and implement quality control measures.
• Statistical Programming Support:
  * Collaborate with statistical programmers to develop and validate programs for data analysis and reporting.
  * Provide input into the development of programming specifications.
• Protocol Development:
  * Contribute to the development of study protocols, including statistical considerations, sample size calculations, and randomization procedures.
  * Provide statistical expertise during protocol review meetings.
• Interpretation of Results:
  * Collaborate with cross-functional teams, including clinical researchers and data scientists, to interpret study results and contribute to the preparation of scientific publications.
• Regulatory Compliance:
  * Ensure compliance with regulatory guidelines, Good Clinical Practice (GCP), and industry standards in statistical analysis and reporting.
  * Contribute to regulatory submissions and participate in interactions with health authorities.
• Statistical Methodologies:
  * Stay current with advancements in statistical methodologies and industry best practices.
  * Apply innovative and appropriate statistical methods to address complex study objectives.

How You'll Get There:

• Master's Degree PhD or MS in Statistics, Biostatistics or other related discipline Required
• - 2-5 years of experience in statistical analysis for clinical trials, preferably in the pharmaceutical or clinical research industry. Required
• - Proficiency in statistical analysis software (e.g., SAS, R). Required
• - Experience with statistical programming and the development of TLF. Required
• - Excellent communication skills, with the ability to effectively communicate statistical concepts to non-statisticians. Required
• - Strong collaboration skills with cross-functional teams. Required
• - Familiarity with regulatory requirements for clinical trial conduct and reporting. Required