- Development of study data tabulation model SDTM and ADaM datasets
- Development of SEND datasets
- Creation of tables, listings, and figures (TLF), in-text tables & appendices
- Support of clinical study report (CSR), integrated summary of safety & efficacy (ISS/ISE), interim analysis, agency filings, safety surveillance & publications
- Support of database edit checks, query creation, patient profiles & ad-hoc reports, as well as data review and monitoring tools such as SpotFire
- Support of data monitoring committee (DMC) meetings as unblinding programmers
- Support for statistical method development, simulations, sample size calculations, exploratory analysis, and research projects
- Acquire sponsor approval on SDTM aCRF, CRT Specification, Datasets and DEFINE.
- Work within sponsor systems and follow their process for version control.
- Ensure aCRF and CRT Specification are validated by an independent SDTM Lead or experienced programmer.
- Validate SDTM datasets via dual independent programming.
- Review reports from Pinnacle 21 Community SDTM datasets and Define.
- Stay up to date with the latest versions of the IG, Controlled Terminology, TAUGs.
- Develop and maintain utilities macros for repetitive tasks.
- Supporting on aggressive timelines such as PMA Analysis
Statistical Programming
Clinical Data Management
- On-shore and off-shore Clinical Data Management Services
- EDC and Paper Trial Set-Up & Management
- Certified Medidata RAVE Builders
- Access to other EDC solutions (Low Cost, Oracle etc.)
- Data Management Plan (DMP) development
- Data Management Project Management
- CRF/eCRF design and development
- CRF Annotation & Review
- Database Build & Design
- Data validation specifications
- Edit checks Programming & Testing
- Data processing through double data entry
Clinical Data Management
- On-shore and off-shore Clinical Data Management Services
- EDC and Paper Trial Set-Up & Management
- Certified Medidata RAVE Builders
- Access to other EDC solutions (Low Cost, Oracle etc.)
- Data Management Plan (DMP) development
- Data Management Project Management
- CRF/eCRF design and development
- CRF Annotation & Review
- Database Build & Design
- Data validation specifications
- Edit checks Programming & Testing
- Data processing through double data entry
Biostatistics
- Support to pre-clinical studies
- Protocol Input
- Randomization/Unblinding
- Statistical Analysis Plan (SAP) and Output Shells
- Clinical Data Interchange Standards Consortium (CDISC)
- Output Production
- Production of Statistical Report/Clinical Study Report
- Interim Analysis/Data Safety Monitoring Boards (DSMBs)
- Meta Analysis
- ISS/ISE