Job Duties Include:
- Support development of Statistical Analysis Plans (SAPs) and the execution of analyses and validation of results
- Performs statistical analyses using packages such as SAS and R in support of presentations, publications, advanced and exploratory analyses, prototyping of standard outputs and general study reporting
- Reviews draft eCRFs, programmed edit checks and data transfer specifications to ensure that all data necessary to meet the objectives of the study are collected appropriately
- Participates in the review of clinical data, including specification of custom review listings and programmatic data checks
- Defines and implements documentation and archival standards for Statistics deliverables and ensures that study documentation is in an audit-refady state
- Ensures that statistics deliverables are produced in accordance with Google Cloud Platform, internal SOPs and all regulatory requirements
- Adheres to all department and company-wide policies regarding conduct, performance and procedures
- Performs other duties as required.
Assist in the statistical design of clinical trials, including authorship of statistical sections of protocols
Responsible for preparation of specifications for study tables, listings and figures (TLFs)
- Knowledge of drug development processes
- Sound understanding of statistics and programming concepts.
- Knowledge of FDA/ICH guidelines and industry standard practices
Independent, innovative, and creative thinking
Collaboration and communication skills
Commitment to the values of integrity, accountability, transparency, scientific rigor and drive.