• Provide statistical input to study protocols for design and analysis of clinical and laboratory trials, randomization, sample size calculations to determine power, and statistical analyses, SAPs and TFL generation and review.• Perform all statistical report writing, calculations, and submissions for precision, method validation, interference, sample degradation, linearity, and studies requiring bias, total error, and random error calculations • Provide statistical input into project development plans, regulatory submissions and questions, interpretation of statistical results, study design, statistical analysis plans, TFLs, and study protocols. • Conduct statistical reviews of TLFs in preparation for regulatory submissions to FDA, EMA, PMDA • Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results, exploratory and meta-analysis results, modeling and simulation in support of various activities, support for publications, scientific presentations, and support to product defense. • Conducted statistical power analyses and sample size calculations w SAS and R for oncology clinical trials.• Cleaned and analyzed clinical data in SAS with various procedures and macros.• Performed statistical analyses including survival analysis, linear regression analysis, longitudinal analysis and logistic regression analysis, and statistical modeling (GLM, Logistic model, Cox model, GEE and Mixed Models) of clinical trials and observational studies using SAS and R.• Participated in preparing the statistical sections and SAPs of clinical study protocols for oncology and rheumatology studies• Present and interpreted methods and results to principal investigators on a regular basis.

Performed duties of a Trial Statistician to support regular clinical trials within national and international development projects. Collaborated with Trial Clinical Monitor and trial teams to plan and support clinical protocols conforming to company and regulatory agency guidelines. Managed other trial Statisticians in their responsibilities. Supported Project Statisticians in their responsibilities in planning and preparation of regulatory submissions and contributed to efforts on cross-trial planning and harmonization. Planned statistical elements of clinical trials in oncology, prepared Statistical Methodology sections for protocols and the Trial Statistical Analysis Plans (TSAPs). Analyzed data from phase I to IV trials incl. responsibility for program validation. Prepared accurate, high quality reports of clinical trials for registration of drugs and biologics, and publications. Prepared specifications for data analyses by outside vendors as required. Reviewed and evaluated proposed case report forms for consistency with information needs for the protocol. Reviewed randomization to be used in the clinical trials. Supported management in resource planning and tracking for assigned trials and projects.