TRUPTI UPADHYAY

Monroe Township, NJ ***** 732-***-**** ad1qls@r.postjobfree.com

PROFESSIONAL SUMMARY

• Certified SAS Professional with over 7 years of experience in the field of Pharmaceuticals and CRO industry.

• Ability to work on multiple projects simultaneously and meet the deadlines as and when required.

• Extensively worked in therapeutic areas such as Oncology, Virology, Respiratory, Diabetology, CNS etc.

• Proficient in generating and validating SDTM, ADAM datasets, TLGs with CDISC standards and summary tables using SAS/BASE.

• Ability to write, debug, and optimize SAS code for data manipulation, analysis, and reporting.

• Validate ADaM datasets using Pinnacle 21 tool and fixing errors, warnings and notices by using SAS.

• Derive responses according to the RECIST criteria to derive Oncology endpoints such as Progression-Free Survival (PFS), Overall Survival (OS) and Best Overall Response (BOR) and Binary endpoint (ORR).

• Creation and validation of E-submission requirements to the FDA which involved – creating annotated CRF, SAS transport files (XPT files), SDTM and ADaM, Define.xml documents, Reviewer’s guide etc.

• Having achieved excellent organizational and communication skills, self-motivated and have experience in leading the team. SKILLS

• SDTM (Study Data Tabulation Model)

• ADaM (Analysis Data Model)

• SAS/ SQL, SAS/STAT

• SAS/Procedures

• SAS/ GRAPHS

• SAS Macros

• ISS

• Oncology

• Oncology Endpoints

WORK HISTORY

Sr. Statistical Programmer, Feb.,2021 - Current

Linical Accelovance, MD (Remote)

• Responsible as a lead SAS programmer to support clinical trial studies for phase I, II and III in Various Therapeutic areas in Pharmaceutical and CRO industry.

• Program datasets according to specifications, created and annotated patient case report forms.

• Generated drafts and final sets of summary data tables and analyses as part of Pinnacle 21 clinical study reports and ISS/ISE documents.

• Assist in validating of various efficacy datasets and graphs such as Forest plot, Scatter plot, Waterfall plot, Kaplan Meier Survival Estimates etc.

• Created and validated SDTM datasets for Intervention (EX, CM), Special-purpose domains (DM, RELREC, SUPPQUAL), Events

(AE, DS, CE), Findings (LB, VS, TU, TR, RS) etc.

• Participated in writing of clinical trial reports, analyzing and presenting trial results and graphs for data review and cleaning.

• Worked effectively on the project about Phase-II -Double blind, Multicentered, Randomized, Active controlled trial in Thyroid Cancer patient and Ovarian Cancer patients to get various statistics by using Proc Freq, Proc Sort, Proc Univariate, Proc Summary, Proc Means, Proc Transpose, Proc Report etc.

• Assisting in deriving RECIST criteria response (OR-Overall Response, BOR and ORR-Objective Response Rate) to derive oncology endpoints such as Primary endpoint and Categorical endpoints.

• Hands-on experience in using PROC FREQ to generate Bi-directional cross frequency counts in lab shift table, summary counts, PROC LIFETEST to generate P-value and 95% Confidence Intervals, Quartiles and Median.

• Independently worked in generating ad-hoc reports using SAS/ODS and proficient in ODS RTF.

• Developed various utility macros (eg., Finding frequency, Converting Date format to ISO 8601 format) and also created standard macros (eg. KM-Plot macros, BOR macro, Visit Window Macros etc.) from the scratch or modified to make it extensively useful. Sr. Statistical Programmer, Feb.,2019 – Jan.,2021

Covance Inc, NJ

• Successfully Handled multiple phases of Clinical trial phase II and III studies and submission simultaneously.

• Reviewed and commented on Protocol, Annotated Case Report Forms(aCRF), Controlled Terminology and Raw Datasets for all studies assigned.

• Participated in Reviewing of Define.xml and created XPT files for transfer (CRT package).

• Involved in the process of generating TLG's for Integrated summaries of efficacy and safety for FDA submission.

• Working on various therapeutic areas including Oncology (TU, TR, RS domains).

• Responsible for creating- ADaM compliant Analysis Datasets with derived variables (including efficacy datasets like ADTTE, ADRS, etc.) according to analysis datasets specifications, RECIST criteria, and SAP (Statistical Analysis Plan).

• Experience in Efficacy analysis for Time-to-Event (PFS) and Binary (ORR) Endpoints.

• Produced KM plots using procedures like TEMPLATE, SGRENDER, LIFETEST and PHREG for survival Analysis.

• Extensively took part in generation of ISS and ISEs for the analysis of clinical trials after doing pooling / integration.

• Provide support for ad-hoc requests to create deliverables and generates reports on safety and efficacy for clinical data analysis.

• Performed QC on numerous studies by independent programming and validated SDTM standards.

• Prepare compliant programming code for regulatory submissions including ADaM datasets, tables, listings, figures and associated documentation.

• Enhanced reports using Proc Report to implement titles, footnotes and SAS System reporting. Statistical Programmer, Oct.,2016 – Jan.,2019

Janssen Pharmaceuticals, NJ

• Generated TLGs in domains of demographics, baseline characteristics, laboratories, vital signs and efficacy.

• Extensively worked with CDISC output for SDTM domains including but not limited to DM, AE, LB, VS, CM, EX, MH etc.

• Participated in efforts to develop ADaM datasets such as Subject-level dataset (ADSL), Basic Data Structure level (BDS - eg., ADRS, ADEFF, ADTTE, ADVS, ADLB) and Occurrences (ADAE) datasets for assigned projects.

• Generated TLFs for PFS (Progression Free Survival), Lab Shift Table, best overall Response, Survival Analysis tables.

• Responsible for providing SAS programming and Analysis support for ISS and CRT packages for submissions.

• Involved in customization of parameters such as Time-to-Event Name, P-value, Hazard Ratio, Censor name, and Number at risk survival/Failure curve.

• Created edit checks programs to find data discrepancies in datasets and maintain issue resolution logs.

• Validated SDTM datasets using PROC COMPARE and worked on patient profiles, AEs of special interest, and protocol deviation listings.

• Proficient in merging of datasets by using Data Step as well as PROC SQL (inner join, left join, full join).

• Extensively involved in legacy analysis dataset creation for sponsor as per requirements.

• Collaborated with biostatisticians and data managers to ensure timely delivery and study results. EDUCATION

Master of Computer Applications : MCA

Indira Gandhi National Open University (IGNOU) - INDIA Bachelor of Science: Computer Science

Sarvajanik College of Engineering & Technology-Surat,Gujarat -INDIA

CERTIFICATIONS

• Successfully completed certificate course of Python 3 Programming – Beginners to Pro from Udemy.

• Successfully completed certificate SAS (Statistical Analysis Software) global certification for Base Programming Using SAS 9.4

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