Principal Statistical Programmer - Katalyst Healthcares & Life Sciences
Bridgewater, NJ 07920
About the Job
Responsibilities:
- Lead statistical programming activities as product lead for full development project or groups of projects in Oncology Therapeutics.
- Attending multi-disciplinary team meetings, representing the statistical programming function.
- Create or review and approve statistical programming plans at study and project level.
- Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.).
- Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies.
- Participate and/or lead in the development and implementation of SAS programming standards, SOPs and work instructions, including program validation and documentation.
- Develop and validate programs (SAS or R) to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies.
- Minimum of 5 years of experience in developing statistical programming deliverables for clinical trials using the SAS system.
- Skilled in programming with SAS. Knowledge of additional programming languages a plus.
- Good knowledge of statistics and Oncology drug development process.
- Ability to manage multiple complex projects and assess resource needs.
- Excellent verbal and written communication within the Biostatistics group and across other functional areas.
- Significant experience in developing SDTM, ADaM and TFLs using SAS or other tools.
- Expertise with CDISC standards.
- Good understanding of clinical standards as well as clinical data sets from major EDC systems (e.g., Medidata Rave, INFORM), safety systems (Argus), and CTMS systems.
Source : Katalyst Healthcares & Life Sciences