KEY TASKS RESPONSIBILITIES
- Develop specifications for SDTM datasets and SDTM datasets specifications for Clinical Data Analysis.
- Develop SAS programming to produce SDTM datasets and SDTM datasets.
- Develop specifications for Analysis Data Model (ADaM) datasets.
- Develop SAS programming and validation of ADaM datasets for trial level reporting and integrated safety and efficacy activities.
- Responsible for developing and maintaining programming and validation specifications for TLGs as per requirements provided by the Biostatistician.
- Create and maintain SAS programs to produce outputs to support the analysis and reporting of clinical trials.
- Program and QC data listings, summaries and Graphs as defined in SAP. If required, validate the statistical models used for programming.
- Develop re-usable utility macros to build a macro library to support programming tables, listing and graphs for phase 1-4 clinical trial reporting.
- Collaborate with the project team to ensure the deliverables are completed on time and with high quality.
- Create submission-ready standard data presentations and data sets using standard coding and following standard industry processes including SDLC.
- Maintain all project documentation as required by SOP and Processes
- Mentor statistical programmers
- Ensure compliance with eClinical Solutions and industry quality standards, guidelines, and procedures.
- Other duties as assigned.
Education/ Language:
- Basic Science/Bachelor of Science degree (Master in Statistics or related science preferred) in health-related field, computer science or equivalent.
- SAS Certified
- Excellent knowledge of English
- Qualified Skills Experience
- Minimum 6 years in Pharmaceutical/Biotechnology industry or equivalent IT consulting role
- Strong experience in preparations for NDA filings
- Strong knowledge of E6, E3, E9 guidelines, 21 CFR Part 11 and clinical trial methodologies
- Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA)
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