Biostatistics & Programming

Biostatistics and statistical programming turn protocol hypotheses into analysis plans, datasets, and outputs that regulators and DSMBs can trust. Viltis supports sponsors and clinical teams with biostatistical consulting and programming aligned to ICH E9 principles, CDISC conventions where required, and the analysis needs of the study. We focus on clarity of estimands, endpoint definitions, and reproducible programming rather than opaque model language. Early involvement during protocol and CRF design prevents analysis problems that only appear after database lock.

Typical work includes statistical analysis plan development or review, sample size and power discussion with clinical leads, randomization and blinding considerations, and interim analysis planning with DSMB charters. On the programming side, we support ADaM and SDTM mapping reviews, Table Figure Listing production, and validation approaches that match your quality system. When vendors deliver analysis packages, we help you review them before submission or database lock decisions. Discrepancies between the SAP, mock shells, and actual outputs are caught while there is still time to correct them.

Late-stage problems often trace back to ambiguous endpoint wording or incomplete data specifications. We prefer to catch those issues early through protocol and CRF review with the biostatistician and data manager in the same conversation. That reduces rework when CSR drafting or Integrated Summary of Efficacy work begins. For adaptive or complex designs, we help document decision rules and analysis populations so the clinical team and DSMB share one interpretation of the plan.

We can staff programming capacity for peak periods, provide independent QC of vendor TFLs, or advise on CDISC mapping when legacy data must feed a submission. The standard is the same: outputs that match the SAP and can be traced to the clinical database without undocumented manual fixes.

Biostatistics and programming support commonly includes

• SAP drafting and peer review
• Estimand and endpoint clarification with clinical
• Randomization and interim analysis planning
• SDTM and ADaM specification review
• TFL programming oversight and QC checks
• DSMB analysis package coordination
• CSR statistical section support

If your study needs statistical planning, programming capacity, or an independent review of vendor outputs before lock or filing, we can staff the work to your timeline and submission standard.