Strategic senior level consulting in clinical development and biostatistics activities; develop clinical strategy from preclinical to registration phase.
Lead role in regulatory submissions in the USA and worldwide.
Timely and successful execution of biostatistics, statistical programming, data management and medical writing activities to meet corporate goals.
Experience in partnering across small, medium and large sized companies and processes.
- 100% Data heavy lifting
- Biostatistics
- Data Standardization
- Full CDM
- SAS Programming
Submission Package
- Reviewers' Guide (cSDRG/nSDRG and ADRG)
- Define.xml
- Data transport
- Programs and datasets final review
- TFL for CSR final review
Data Standardization
- SDTM
- ADaM
Statistical Analysis
- Draft the statistical chapter in both of clinical study synopsis and protocol
- Study design
- Sample size calculation
- Draft Statistical Analysis Plan (SAP)
- Provide statistical support for Data and safety monitoring Board (DSMB)
- Draft Statistical Analysis Report and statistical part in CSR (Clinical Study Report)
- Meta analysis service
SAS Programming
- Data manipulation
- Ad-hoc analysis for clinical trial studies
- Generate and validate Statistical TFL (Table, listing and figures)
Special Projects
Clinical data across a sponsor program often gets collected through disparate data capture systems, sometimes in files, each with its own non-CDISC naming conventions and field characteristics. Pooling is required for various purposes. Example of current project: pooling 21 individual studies (3 phase III studies, 5 phase II studies and 13 phase I studies) together into one raw database, to then generate SDTM/ADaM datasets, final TFL outputs, and the biostatistical portion of the submission package to support the sponsor’s NDA submission.