We are hiring a Biostatistician to be located in the San Diego area!
San Diego Metro Area, CA
- Provide timely and scientifically sound statistical expertise to clinical development projects.
- Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies.
- Work closely with data management, clinical operations, programming, and other biostatisticians to develop and validate study-specific data capture systems
- Develop statistical analysis plans (SAPs) to meet regulatory standards, coordinate and perform data analysis and validation as necessary, and provide data interpretation.
- Produces table, figure, and listing templates for reporting of study results and data
- PhD degree in Statistics or Biostatistics with some applied statistics training relevant to the clinical trials or health research environment, and with a minimum of three (4) years of relevant work experience OR a Masters degree in Statistics or Biostatistics or a related health science field, and a minimum of six (6) years of biostatistical experience in the clinical trials or health research environment.
- Knowledge of CDISC requirements for SDTM and ADaM
- Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
- Comprehensive knowledge of statistical methodology in design and analysis, and regulatory requirements relating to clinical development of drugs and biologics