
Career Opportunities in Statistical Data Analysis
2 semanas atrás
The primary objective of this role is to create, maintain, and validate electronic data capture forms (eCRFs), as well as specifications and statistical programming of study data tabulation models (SDTMs), analysis data models (ADaMs), derived datasets, tables, listings, and figures (TLFs). The Statistical Programmer will also support data managers with data cleaning activities, use global SAS macros, participate in internal initiatives to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TLFs, and use Pinnacle 21 to validate SDTMs, ADaMs, and define.XMLs.
Main Responsibilities- Adhere to Company Values and Procedures: Follow company standard operating procedures (SOPs) and processes for all deliverables, and ensure all trainings assigned to oneself are completed on time.
- Review Scope of Work and Budget: Identify tasks that are out of scope at initiation of clinical trials.
- Support Data Managers: Program, report, review, and close statistical data issues in collaboration with other Statistical Programmers and Lead Biostatistician.
- eCRF Development: Develop/maintain/validate aCRFs according to protocol, eCRF, and Sponsor's standards and interpretation of CDISC SDTM IG and CT.
- Specifications and Programming: Develop/maintain/validate specifications and primary or QC statistical programming (as applicable) of SDTMs, ADaMs (or derived datasets, as applicable), and TLFs.
- Data Validation: Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21.
- Maintenance and Updates: Use global SAS macros to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TLFs.
- Quality Assurance: Contribute to the identification of future internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables and participate in the realization of these internal initiatives.
- Knowledge Updates: Keep oneself abreast with latest industry and CDISC standards as well as ICH and Regulatory Authority guidance and requirements.
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