Sanketkumar Patel Email & Phone Number

Philadelphia, Pa, Us

Rahway, New Jersey, Us

North Chicago, Illinois, Us

• Leading high visibility oncology studies across various indications.• Created Oncology and Radiology dossiers for the IRC assessments by the third-party vendor.• Re-derived investigator responses using the response criteria and documents provided by the statisticians for IWG2023, IMWG2018, DACOGEN , IMWG2018 criteria. created complex efficacy end points for hematology like CR, PR, PD, MR, VGPR, HI-E Minor, HI-E major, Relapse etc.• Experienced with preparing the Module 2/Module 5 components of eCTD.• Created casebook, patient narratives, trial disclosure files etc.• Experienced with MHRA inspection readiness for oncology studies.• Worked with CDSO, DWA, DSA, DA and provided them with programming support to identify any data issues and data quality check for locking the database in timely manner.• Working closely with different stakeholders in the drug development process like medical directors, regulatory affairs specialists, market access, HEOR, patient experience, CPPM, PK scientists, Statisticians, Medical writers, patient safety etc.• As a study lead and hands-on programmer, worked on creating ADAM specifications from scratch, deriving ADAM datasets for safety and efficacy, creating TFLs and preparing the submission packages using P21E.• Responsible for in-depth review of the SAP, SPP and MOCKS created by statisticians and providing the comments.• Responsible for maintaining the TMF (validation plan, validation report, derived dataset form , external transfer form etc.) and other documentation for the studies I am leading.• Provide Vendor oversight for deliverables and oversee the work and assignments of programming Contractors. • Experienced with forecasting workload and creating timelines.

Dublin, Ie

• With extensive experience in Oncology Therapeutic area, also worked on other therapeutic areas like Cardiovascular, pain, urinary incontinence, NASH studies etc.• More than 2 years of experience working with Pfizer CDARS tool.• Generated different tables, listings and graphs as requested by Statisticians.• Worked in creating Analysis datasets (Safety/Efficacy) and safety/efficacy tables, listing andPlots using macros.• Meet objectives as assigned and interact with the project team to organize timelines,responsibilities and deliverables.• Understand and comply with core operating procedures and working instructions.• QC of Analysis datasets programmed by other programmers by parallel programming.• Extensively Involved in writing specifications for Safety datasets (ADSL , ADAE , ADLB etc.)and Efficacay datasets (ADRS , ADTM , ADTTE , ADEFF) for many oncology studiesaccording to SAP ,CRF, Mock shells and protocol.Progression free survival, Time to Progression, Time to failure, Duration of Complete response and Partial response, Overall survival, time to anti-cancer therapy free survival etc.• Expertised in creating lab shift tables .• Extensively used PROC LIFETEST, PROC PHREG to predict and study the timing of events, efficacy endpoints of clinical trials.• Involved in creating datasets for adverse events clustering as per clustering document provided by client. Also created complex time to event dataset for adverse events.• Assisted in preparing electronic submissions package (Define.XML, Define.PDF, ADRG, XPTfiles) for FDA submissions using Pinnacle21.• Worked as co-lead for several projects and involved in meetings with clients negotiatingtimelines and resolving issues and questions from programmers.• Involved in creating mock-ups as per SAP requirements and writing specifications from scratchbased on SAP, mocks and protocol.and complex graphs/Plots Like swimmer plots, forest plots, waterfall plots, Needle plots, Spiderplots etc

Philadelphia, Pennsylvania, Us

Involved in analysis of Phase II and III clinical trials.Performed QC of derived datasets, TLG’s and coded programs and involved in Data Validation. Extensively worked on Oncology listings, Summary tables, figures and Oncology endpointslike Progression-free survival methods, Time to Progression, Duration of Complete response and Partial response, Overall survival.Extensively used PROC LIFETEST to predict and study the timing of events, efficacy Endpoints of clinical trials.Assisted Bio-statistician in computing different statistics using PROC ANOVA, PROC GLM, and PROC MIXED etc.Prepared analysis datasets for PK/PD analysis for analyzing AUC and Cmax, Tmax.

Master Of Science - Ms, Pharmaceutics And Biostatistics

Bachelor'S Degree, Pharmaceutical Sciences