Principal Biostatistician

What You'll Do:

• Statistical Analysis:
  * Leads multiple development programs, potentially directing junior staff in statistical analyses for clinical trials, including the development and implementation of statistical analysis plans (SAP) and generation of tables, listings and figures (TLFs) to support 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.
  * Drive investigation and resolution of data discrepancies and implementation of 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 like selection of endpoints and sample size calculations.
  * Provide statistical guidance to cross-functional protocol development teams.
• Interpretation of Results:
  * Seen as key opinion leader on cross-functional teams, including clinical researchers and data scientists, in interpretation of study results

* Propose ideas 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.
  * Possess high level of understanding of regulatory filings and participate in interactions with health authorities.
• Statistical Methodologies:
  * Seek to learn, implement, and train on innovations in statistical methodologies and industry best practices.
  * Anticipate potential complex problems and spearhead appropriate in depth analyses to address

How You'll Get There:

• Master's Degree PhD or MS in Statistics, Biostatistics or other Scientific discipline Required
• minimum of 10-12 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). 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