Surya Chitra Email & Phone Number

Wilmington, DE, US

• 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.
• 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).
• 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.
• 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

Newark, DE, US

Teach Graduate courses in Operations Research and Statistics.

Malvern, PA, US

• 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.
• 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)

Raleigh, North Carolina, US

• 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..
• 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.

• 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.
• 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.

Cambridge, Cambridgeshire, GB

• 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.
• 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

• 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.
• 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

Chester, PA, US

Teach Graduate and Undergraduate Statistics for Scientists and Engineers

Describe your position

.

Phd, Chemical Engineering/Statistics

Mba, Finance & International Business