Principal Statistical Programmer - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 08540
About the Job
Responsibilities:
- Provides SAS programming support to all clinical studies.
- Manages programming CROs providing oversight and appropriate QC for programming deliverables.
- Provide expertise in statistical programming for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD).
- Provides primary programming and QC support for any internally produced outputs.
- Reviews and approves SAS programming instructions and CDISC/ADaM.
- Perform complex statistical analysis and simulations using SAS to support clinical trial design and data interpretation.
- Reviews and provides input on eCRF design, external vendor data specifications, edit checks, and other Data Management related documents to ensure appropriate data collection for statistical programming.
- Works closely with biostatisticians and data managers to identify data issues and generate queries that may impact statistical analysis and/or programming.
- Knowledge of pharmaceutical and regulatory requirements, procedures, and policies with a minimum of 5 years of pharmaceutical experience.
- Experience with BLA or NDA/sNDA submissions is required.
- Knowledge of GCP, ICH, 21 CFR part 11, and other Guidance documents and policies related to clinical trials operations requirements.
- Knowledge of CDISC and Adam dataset structures and requirements.
- Knowledge of all aspects of clinical drug development (Phase 1-4).
- Experience working with and managing a CRO partner.
- Excellent computer skills; strong verbal and written communication skills.
- Ability to work well in a team environment as a contributor.
Source : Katalyst Healthcares & Life Sciences