Clinical SAS Programmer - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
About the Job
Responsibilities:
- SAS Programming: You'll utilize advanced SAS programming skills to analyse and report clinical trial data (both safety and efficacy).
- CDISC Standards: Proficiency in CDISC standards (SDTM & ADaM) is essential. You'll generate and validate SDTM and ADaM datasets, as well as create tables, listings, and figures (TLFs).
- Study Lead: Experience juggling multiple projects simultaneously is preferred.
- Submission Documents: You'll create and review submission documents and electronic case report forms (eCRTs).
- Collaboration: Effective communication with cross-functional teams and clients is crucial.
- Assists the Senior Director of Biometrics in providing statistical consultation for clinical programs, including randomization, sample size assessments, efficacy evaluations, and data review.
- Develops statistical analysis plans, including textual descriptions of planned analyses and mock-ups of data displays.
- Provides tabular and written summaries of analyses and statistical methodology.
- Ensures accurate programming of SAS clinical data extracts and data displays.
- Develops programming specifications, including analysis datasets and tables/listings/figures.
- Supports and/or leads programming for analysis datasets, TFLs, or standard tools following standard data models or user requirements.
- Ensures the integration of data across studies in support of CSS/CSE.
- Builds, leads, and maintains programming specifications for analysis datasets using tools and methodologies.
- Supports the creation and validation of submission requirements (e.g., annotated CRF, data export files, define documents).
- Interfaces with CRO to ensure data and statistical reporting is secure and timely.
- Proactively identifies risks, developing and implementing mitigation plans as applicable.
- Participates in study and department meetings, preparing agendas and minutes, and maintaining key decision and action item logs.
- May assist study teams and departments with financial tracking and reporting, including coordination of CRO, vendor, and site contracts.
- May assist in developing policies and procedures (SOPs).
- Additional tasks and projects as requested.
- Works in a multidisciplinary study team to provide timely and quality support for the analysis and reporting of clinical trials up to regulatory approval, product launch, and annual reports.
- If applicable, develops and provides department training for applications and standard tools developed by the department functions group.
- MS. (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field.
- Experience: At least 8 years of SAS programming experience with clinical trial data in the Pharmaceutical & Biotech industry (with a bachelor's degree) or 6 years with a master's degree or above.
- Familiarity with statistical principles, CDISC data, and standards.
- Proficiency in SAS programming skills in a clinical data environment with excellent analytical skills. Knowledge of other programming languages such as R, Python etc.
- Good knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles). Knowledge of regulatory submissions and requirements is a plus
- SAS, (Base, Stat, Macro, graph); SAS certificates a plus.
Source : Katalyst Healthcares & Life Sciences