Summary of Responsibilities
Advanced Clinical is currently seeking a Biostatistician is responsible for providing statistical support and SAS programming support for clinical trials. This includes participating in SAP development, preparing and reviewing programming specifications, analyzing data and reviewing case report forms (CRFs), and database structures.
- Apply knowledge of statistics, statistical programming and pharmaceutical regulations to fulfill primary duties.
- Prepare and review statistical analysis plans (including shell tables, listings, and figures).
- Prepare and review programming specifications used in creating analysis datasets, tables, listings, and figures.
- Perform efficacy and safety analyses for clinical trials data and participate in validation and quality control of statistical output.
- Contribute to the development and improvement of standards for statistical activities.
- Work closely with data management and database teams in the development of CRFs, database specifications, and database validation checks.
- Implement and support CDISC (both SDTM and ADaM) and other regulatory standards.
- Follow Standard Operating Procedures (SOPs)
- Assists with creating, revising, and reviewing SOPs as needed
- Master’s Degree in Statistics or a related field with a minimum of 1 year experience analyzing clinical trial data in a pharmaceutical or CRO setting.
- Perm US work authorization is required.
Advanced Clinical is an Equal Opportunity Employer, M/F/D/V.