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