• Author and provide input on 200+ research protocols, including endpoint specification, sample size determination/justification, SAPs for clinical trials, CRFs, TLFs, ad-hoc statistical analysis and CSRs.• Work in collaboration with Bioinformatics team on analyzing data for oncology MRD Assays based on Illumina NGS platforms. • Provide statistical expertise to support submission activities and documents, responses to regulatory authorities and other diagnostic assay development activities.• Mentor the Statistics and R&D team to facilitate thorough knowledge of validation and verification procedures.

* Managed the biostatistics component of FLT3 Mutation Assay development. • Explored and analyzed data to establish assay specifications. • Conducted DOE and comparison studies to optimize the assay.* Made key contributions to PMA submission. • Designed experimental studies, wrote and reviewed protocols, cleaned and organized data, accomplished data analyses and produced reports for analytical validation, reagent and specimen stability studies: • Worked with my counterpart at Novartis to prepare SAP, carried out data analysis and developed reports for Clinical Bridging study – this study demonstrates agreement between results of the FLT3 Mutation Assay (companion diagnostic for midostaurin) and the Phase III clinical trial assay on banked AML samples from the trial, estimates drug efficacy, and includes other supporting analyses. • Participated in writing responses to FDA PMA questions and deficiency letters.* Performed protocol and report reviews, provided statistical input and data analyses for different NGS projects and submissions.* Advised all members of the company on study design, methods, use and interpretation of statistics and results, and implementation of JMP

* Provided statistical expertise to design clinical development plans in GI and cancer research.• Provided input to clinical study protocols and case report forms.• Defined analysis endpoints, statistical methodology and sample size for clinical trials.* Defined and executed analyses, prepared statistical analysis plans, generated statistical analysis reports and interpreted statistical results. • Projects included late stage observational clinical trials, Registries, sNDA, diagnostic sample collection, and diagnostic clinical utility studies.* Prepared and reviewed integrated statistical and clinical reports including summary statistics, graphics, tabulations and raw data listings for clinical studies. * Planned and directed study-level statistics activities including work of other statisticians, programmers and contract research organizations (CROs); mentored all personnel levels on statistical concepts.* Supported publications, abstracts, manuscripts, and presentations.* Retrospectively reviewed data for potential regulatory action and confirmation of information included in previous submissions.* Coordinated data summarization and analysis with statistical programmers, writers and clinicians. * Contributed to definition of project level database, analysis and reporting standards

* Analyzed complicated clinical data to develop algorithms to enhance clinical utilities of diagnostic instruments.• Improved screening accuracy of the existing screening algorithm for disease detection by introducing a new parameter which improved the discriminating power (sensitivity/specificity and ROC analyses).• Engaged in the research and development of methods to combine structural and functional measurements to assess disease stage (factor, cluster, correlation and regression analyses) • Engaged in the development of algorithm for detecting disease progression based on nerve fiber layer imaging. * Develop study design and data analysis plan. Complete sample size calculations and statistical analysis for different studies. Generate statistical analysis reports.* Performed data review, preparation and cleaning.* Prepared and analyzed data for normative database development.* Explored clinical data to facilitate better understanding of available diagnostic instruments in terms of early detection capability, dynamic range of each device, test-retest variability, and limitations of each device.• Completed Gage R&R analyses for different medical device.• Performed compatibility analysis of hardware platforms (variance components analysis, concordance correlation, Deming regression, Bland-Altman limits of agreement).• Compared different diagnostic tools.• Provided assessment of new features impact on device measurements. * Advised engineers, scientists, and product managers on study design, methods, use and interpretation of statistics and results.

• Performed statistical analysis of Wayfinding Survey to determine what type of information consumers with visual impairments feel they need most, is hardest to get, and is most important to them when traveling independently. Used factor analysis on variables in ease/importance categories overall and for each of the groups. Identified level of association between variables of interest. Carried out group comparisons. Determined confounding variables.• Verified and cleaned data, making variables ready for analysis.• Performed annual data analysis on sports program for visually impaired children.

• Performed analysis to review if a short global Visual Analogue Scale rating for well-being in patients recently diagnosed with terminal cancer provided a good approximation for overall measures of quality of life using European Organization for Research and Treatment of Cancer (EORTC) scales. Carried out correlation analyses among the corresponding items on both scales. Used backward regression to find significant predictors of both scales for VAS well-being and EORTC overall quality of life.• Validated the Palliative Prognostic (PaP) Score in an inception and representative cohort of terminal cancer patients seen in earlier rather than later stages of their terminal phase. Calculated a prognostic score according to PaP for each patient with terminal cancer of lung, breast, and gastrointestinal tract. Using standard Receiving Operating Curve (ROC) methods, determined the best cut-off values for prognostic scores to identify groups of patients surviving up to two, four, and six months. Calculated indicators of accuracy, including sensitivity, specificity, PPV, NPV, LR+, and LR- likelihood ratios to predict survival.

• Performed an analysis to detect any differences between PRN (Practice Research Network) and CPA (Canadian Psychiatric Association) among locations of practice across Canada and within a province separately.