Teams at Innovaderm Research

Supports and leads biostatistical activities across Phase 1–4 clinical trials, including protocol design, sample size calculations, risk-based monitoring, data management, SAPs, TLF shells, CDISC dataset and output review, clinical study reports, and statistical programming teams. Manages deliverable timelines, budgets, forecasting, and quality standards while collaborating with sponsors, vendors, project teams, and regulatory stakeholders. May also support unblinded analyses, randomization, interim analyses, and internal research projects.

Provides statistical expertise across Phase I–IV clinical trials, including protocol design, sample size and power calculations, randomization, statistical analysis plans, data interpretation, clinical study reports, regulatory submissions, SOPs, and client communication. Collaborates with clinical trial teams, supports research and development, and ensures work meets regulatory, industry, sponsor, and timeline requirements.

Maintains Trial Master Files throughout clinical studies by reviewing, classifying, and quality-checking records, resolving queries, tracking milestones and expected documents, preparing metrics and reports, and coordinating TMF reviews and closeout. Independently leads TMF activities for limited-scope investigator-initiated and sponsored studies, including management plans, indexes, meetings, completeness reviews, and issue escalation. The role also supports process improvements and computerized-system administration.