Provided statistical oversight for multiple Phase I-III projects, including new drug and indication registrations across oncology, rheumatology, autoimmune, and orphan diseases. Consulted with Clinical Research Scientists on trial design and its statistical considerations, calculated sample sizes, and wrote the statistical sections of the protocols. Performed efficacy statistical analysis of trial data. Pioneered Exposure-Response analysis in the company, resulting in successful drug registrations. Created and QCed SAPs and other study documents. Provided ongoing biostatistical consultancy to other functions such as Medical Writers, Marketing, Pharmacometrics, and SAS programmers. Coached personnel on advanced statistical concepts, such as estimands. Contributed to process improvements within my division.

Provided benefit-risk assessments of Russian-produced and imported drugs and biologics based on clinical trial reports in various therapeutic areas (primarily oncology and infectious diseases), including the evaluation of marketing authorization applications and post-authorization assessments of medicinal product safety and efficacy profiles. Conducted biostatistical reviews of clinical trial protocols for clinical trial applications in Russia and the Eurasian Economic Union. Performed complex statistical analyses of clinical trial data. Carried out scientific and methodological support for the evaluation of preclinical and clinical data, including the development and writing of internal recommendations for regulatory staff. Held biostatistical training sessions for stakeholders in the field of drug development.