• Statistical & Oncology Biomarker Consultant- GENENTECH/ROCHE (1/2016 – 1/2019) - Study/Project Statistician, Phase 2b aPDL-1 (Atezolizumab) combination NHL studies - Bayesian predictive modeling for decision-making scenario-building - Development of Go/No Go criteria decisions to move to Phase 3 studies - Statistical Analyses-prognostic/predictive biomarkers (including Gene Exp. Data) - Interacted with FDA on Study designs for NHL indication (Single/multiple arm trials) - Supported Clinical/Medical Affairs Teams for publications & Presentations• Clinical Statistical consultant - PARATEK PHARMACEUTICALS (1/2015 –1/2016, 12/2018-6/2020) - PK data analyses (WinNonlin and SAS) including PK simulations for dose-finding - Study Statistician for (Single/Multiple Arm) studies for a new antibiotic drug - Unblinded data review and predictive probability models for decision making - Statistical support for Non-clinical development including CMC and clinical operationso - Stats Team Lead for NDA Submission & RFI Analyses - Lead and attended FDA Type C meetings for all drug developmental reviews - Participated and Lead the FDA Advisory Committee Mtg Prep and Data Analyses• Statistician & Analytical Consultant – ITUS HEALTH LLC. (5/2015 – 1/2016) - Conducted healthcare analytics and developed proposals • Clinical Bio-statistical Consultant – PAIN REFORM Ltd. (1/2015 – 4/2015) - Attended and lead the Pre-IND (Type B) meetings facing FDA team for client - Phase 3 designs/Protocol development for post-operative Pain treatment clinical studies • Consulting Biostatistician - ASANA BIOSCIENCES LLC. (3/2015 – 1/2016) - Phase 1 (Single Arm) design for Oncology Solid Tumors and Prostrate Cancer clinical studies

Treasurer and Finance Committee Chairman

Teach Graduate courses in Operations Research and Statistics.

As director and head of biostatistics, I was responsible for managing compounds in R&D, pre- and/or post-approval for all statistical aspects of the drug development and managing a group of statisticians and programmers, including Regulatory interactions, study design, statistical methodology, regulatory submission and/or post-approval activities. Assisted in due diligence activities, coordinated statistical/programming support, and managed external contractors/CROs when necessary. • Led and Supported HEOR/Medical Affairs teams for analyses of scientific data • Developed clinical strategy/ designs for Phase I-III (Single Arm and Multiple Arm) trials• Worked on delivering non-clinical submission studies (Stability & Dissolution) • Developed and implemented Statistical Analysis Plans (including ISS and ISE)• Acted as consultant for manufacturing data analysis needs (QC, specifications, QbD and DOE)• Contributed to Clinical Study Reports and other regulatory submission documents• Participated and contributed in Type C meetings with regulators (e.g. FDA, EMEA)• Organized and led the internal/external data monitoring committee meetings• Participated in Due Diligence activities and contributed to the strategy discussions• Managed project team and interacted with external vendors for a major NDA Submission

As a pharmacology and biostatistics group leader for the Specialized Pharmaceutical Services, provided statistical and pharmacokinetics consulting/analyses for sponsors for Manufacturing and Development projects. Developed statistical methodologies for clinical and non-clinical data analyses. Developed IND plans including review of preclinical and CMC dossier for new programs. Led and managed a group of biostatisticians and SAS programmers. Projects involved start-up to established pharmaceutical companies working in CV, Vaccines, and Oncology therapeutic areas. • Provide strategic guidance for PK/Pharmacology (Phase I-III) developmental plans for clients. • Developed adaptive designs for FDA Type C meetings for Phase II/III trials for a client• Stats Lead for FDA Type B (Pre-IND) meetings for a small Oncology Biotech company • Prepared RFP responses and participated in bid defenses to win the RFP bids successfully. • Presented PK/Biomarker plans/strategies to potential clients during the bid defense meetings. • Developed SAP, PK plan, Regulatory Plans, Scientific Advisory Prep, Clinical Study Reports. • Conducted Statistical Analyses to support Medical Affairs and HEOR Teams

Performed and delivered Exploratory and Clinical/Non-clinical Data Analysis projects for the Pharmaceutical and Healthcare industries. Developed clinical development strategies from idea to proof of concept/action stages of drug development for start-up biotechnology companies. Major clients include:PharmaNet, Princeton, NJPharmacokinetics and Biostatistics/Clinical Pharmacology Projects: • As a statistician to the Client’s HEOR Group performed Statistical Analyses for Publications.• Analyzed and prepared PK and Statistical analyses for Phase 1/2 studies.• Developed exploratory statistical analysis for adverse events and patient safety data • Developed PK/Statistical analysis plans, and clinical development plans for clientsChristiana Hospital, Wilmington, DE Data Analysis and Biostatistics • Variance/ covariance modeling using SAS for the analysis of lab provider data.• Prepared Statistical Analysis Plans for Hospital Initiated and sponsored Clinical trialsHealthCore, Wilmington, DE Statistical and Data Analysis • Used SAS logistic regression and probability models to create the value at risk models.• Developed Statistical Procedures and SAS programs for analysis of proprietary Healthcare data• Cross-validated Risk Analysis Programs according to Statistical design.

Responsible for providing data related strategic and operational leadership to delivery teams involving up to 30 or more professionals for delivering clinical submission package. Hands-on work with biostatistics (Clinical and Non-clinical) and PK/Population PK Analysis tools for clinical trials.• Led a group of Biostatisticians for clinical pharmacology projects• Led and provided input for protocols, study reports, and IND submissions • Developed single/multiple arm studies for Inhalation Device for COPD• Performed and led statistical analyses projects for several NDEs from preclinical to clinical stage. • Performed biostatistical analysis using SAS and S-Plus for clinical/non-clinical projects• Worked on pre-clinical pharmacology documents for Pre-IND/sNDA submission for FDA.• Worked with the teams to develop PK sampling, randomizations, and PK/statistical analysis plans.

The primary focus was to rapidly launch the Phase IV Program to evaluate the treatment GAP in statin usage for CHF and CHD patients to grow the statin (ZOCOR ®) market share. Worked on statistical analysis using SAS and data mining tools. Acted as a project manager and a Statistician between Merck and the CRO in delivering the publication data, results, and reports.• Designed & developed statistical analyses for Merck’s Medical Affairs/HEOR teams • Performed preliminary data analysis to check data validity on the chart review data.• Involved in the development of chart review data tables and analysis• Developed and validated data listings, summary tables, graphs and charts for final analyses

Teach Graduate and Undergraduate Statistics for Scientists and Engineers

Describe your position

.