Principal Statistical Programmer - Katalyst Healthcares & Life Sciences

Responsibilities & Requireme3nts:

• Utilize advanced SAS programming skills to analyze and report clinical trial data .

• 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).

• Experience juggling multiple projects simultaneously is preferred.

• You'll create and review submission documents and electronic case report forms (eCRTs).

• 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

• 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.