Biostatistics

• Study design and protocol development.
• Sample size calculations.
• Statistical Analysis Plan.
• Randomization listing.
• Write and validate SAS code of inferential TLGs.
• Interim analysis.
• Exploratory analysis.
• Outcomes research.
• Independent Statistician.
• DSMB Statistician.
• Assist Advisory and Expert Groups for complex analyses.
• Assist in writing of Clinical Study Report.
• Oversee CRO teams of data management and statistical programming.

SAS Statistical Programming

• Program and validate efficacy and safety TLGs.
• Review database periodic transfers.
• Create analysis database complying with CDISC standard.
• Perform critical checks on raw and analysis database.
• Write programming specifications document.
• Validate SAS programs and macros.
• Program integrated database.
• Prepare validation report.

Medical Writing and Publications Support

• Write and review clinical study protocol statistical section.
• Write and review clinical study report.
• Assist in additional analysis for publications and interpretation of results.