Address
Form of work Responsibilities:
- Manage programming activities on project or study level, including managing CROs to ensure deliverables are accurate and compliant.
- Act as a Programming SME for assigned studies, including authoring/reviewing programming specifications, such as SDTM/ADaM specifications, TFLs creation and QC for reporting events, eSUB packages, and documenting production and validation programs.
- Apply programming skills to support statistical analysis, clinical reporting, regulatory submissions, Ad-Hoc/post-Hoc requests, and scientific publications.
- Work with Biostatistics and other functions for the development and maintenance of the data review and reporting tools, e.g., aCRF, SAP, and mock review, and any other statistical applications as appropriate.
- Work with CRO counterpart on project timeline management; oversee and provide input on statistical programming activities, ensure timely and quality delivery.
- Follow good programming practices, create, and validate global SAS macros and utilities to automate standard and frequent tasks, enhance quality and efficiency.
- A minimum of a bachelor's degree in a scientific, computer science or related field, training in statistics preferred.
- A Principal Statistical Programmer requires a minimum of 8 years of statistical programming. An equivalent combination of education and experience may be considered
- A Senior Statistical Programmer requires a minimum of 5 years of statistical programming. An equivalent combination of education and experience may be considered.
- Experience in a pharma, biotech, or CRO environment is required.
- Knowledge of multiple phases of clinical development and experience in using SAS for clinical trials TFL report and/or integrated analysis for regulatory submissions.
- Hands-on experience and in-depth knowledge in CDISC standards, including SDTM and ADaM, controlled terminologies, aCRF, cSDRG, ADRG, Pinnacle 21 reports, and define xml.
- Excellent knowledge of SAS/Macro, SAS/SQL, SAS/GRAPH, and SAS/STAT; advanced SAS programming ability to implement standard statistical analyses; experience in developing SAS macros to standardize the workflow and internal processes.
