What are the responsibilities and job description for the Principal Statistical Programmer position at Katalyst Healthcares and Life Sciences?
Responsibilities :
- 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 (escorts).
- 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.
Requirements :
