Data Clinical Research
Resume:
PARDEEP VOHRA
********.***@*****.***
PROFILE SUMMARY
Highly adaptable SAS Programmer Analyst with proficiency in SAS and managing large data sets. Creative problem-solver with proven aptitude to analyze and translate complex customer requirements and business problems while designing/implementing innovative custom solutions. Seeking a mid level SAS / Data Management / Clinical Operations and Research position to integrate my experience in the Pharmaceutical Industry and SAS training to help a company improve its bottom line.
TECHNICALSUMMARY
Seasoned professional with 6 year experience in the Pharmaceutical/CRO Industry for various Phase I-III Clinical Trial Studies.
Experience with BASE/SAS, SAS/GRAPH, SAS/STAT, SAS/MACROS and SAS/ODS.
Extensively worked in writing SAS programs for creating Tables, Listings and Adhoc reports.
Thorough knowledge of Clinical Study fundamentals, Clinical Trials (Phase 1-1V, Safety and Efficacy), Phases of Clinical Study, Modern Study Design and Common Terminology.
Excellent understanding of FDA guidelines, 21 CFR Part 11, IBs, ICH and GCP guidelines and other documents - Protocol, CRF, CDISC-SDTM Fundamentals - General Observation Classes, Trial Design domains, Nomenclature for SDTM and ADaM and Pinnacle 21 (OCV).
Worked on different clinical trials data like Demographic, Adverse Events, Laboratory, Concomitant, Vitals in therapeutic areas such as Oncology, Cardiovascular & Hypertension.
Ability to handle related projects, resolve, QC complicated issues as a team member.
Experience with Concatenating, Interleaving & Merging SAS datasets, enhancing reports and producing summary reports.
Experience in producing HTML, RTF & PDF formatted Adhoc reports using SAS ODS for presentation and further analysis.
Experience in Extracting data from different sources using Proc Import procedure, Infile, Libname, Filename statements and SQL pass through facility.
Experience with Manual Data Quality Checks (DQC), Data Review Listings, Data Extracts, Data Mapping from and Importing External Data Files.
Strong Experience in CRF Annotations & review for multiple studies as per CDISC compliance.
Familiarity with Rave Study in mapping Rave Specifications document in accordance with Post-Processing Guide for Rave Extracts V1.2 / V2.0, CRF, MedDRA/WHO-DD codes.
Proficient in Validation skills for Tables, Listings and annotated CRF.
Attended and participated in client meetings as requested on weekly/daily basis.
Excellent interpersonal & Good communication skills & capable of handling Multiple Tasks and ability to interact with members of different functional areas to obtain information and coordinate activities and active participation in weekly/monthly meetings with diff vendors.
Familiar with all the activities of Clinical Trial Operations which are used in Clinical trials Research and Data Management.
Familiar with Central Monitoring/Auditing which includes areas such as working with Sites, Principal Investigators, Reviewing Protocols and provide feedback, Medidata RAVE EDC, IVRS, IWRS, Audit Trails, SDV vs EDC, Indications, Handling system and manual queries with the site, Regulatory doc collection, Query resolution, AE collection, ICF handling, Maintain timely deliverables, Handling Investigator Brochures (IBs), Sufficient knowledge on MedDRA and Handling and reporting SAEs to DSMB, FDA (central body), IRB (local body) for adjudication and maintaining liason between the site and the sponsor and also an overview on O*C - RDC.
4 years experience in Office & Clerical duties - Typing, Managing Supplies, Data Entry, Scheduling, MS Word, MS Excel, Team Person, Accurate, Detail-Oriented, Persuasive, Quick Learning & Adaptability to different environments, Organized, Ready to travel and a US Citizen.
TECHNICAL SKILLS
SAS: SAS V9.4, SAS/BASE, SAS/MACRO, SAS/GRAPH, SAS/STAT, SAS/ACCESS, SAS/ODS.
Operating Systems: Windows 2003 Server, Windows NT/2000/XP.
Databases: MS Excel, MS Access.
PROFESSIONAL EXPERIENCE
Clinical SAS QC DM Programmer:
Client: Boehringer Ingelheim Pharmaceuticals, CT (Jul 2015 - Jul 2017)
Validated SDTM datasets according to SDTM IG 3.2, SDTM 1.4 and CDISC CT by using company standard SAS programs and validated CRF annotations on request by TDMs.
Compared QC data with the primary programmer data created by company transformation macro using proc compare, proc freq and proc print procedures.
Reviewed all the documents such as CRF, Protocol, Source datasets, OCV findings community tool per Company level, SDTM IG, CDISC CT, DTAs, FDA rulings, FDA Business rules and Rejection Criteria for data accuracy before final submission with FDA.
Generated OCV (Pinnacle21) reports regularly on weekly basis, reviewed data compliance with company standards and forward issues to the team for investigation.
Created Issue Log files in excel on finding discrepancies for multiple studies for tracking issues status and for future reference to save time during DSUR, DSMB deliverables.
Handled QC and documented Open CDISC Validator Reports (OCV) for FDA submission for more than 15 clinical trials and forwarded issues to the study programmers or Standards Group for further clarification or modifications if any.
Reviewed company QC package for trials, running it on regular weekly / bi-weekly basis before a final review by TDMs and PDM to resolve data issues with the site.
Provided issue related guidance to all the TDM’s and transformation programmers on regular basis and helped them in submission.
Participated in regular weekly Team/DM meetings and addressed all the issues in e.g., trial design domains like TA, TE, TI, TV, TS and validation of CRF annotations.
Assisted in establishing company data standards by working with standards team.
Worked directly with SGA (the standards group), by suggesting enhancements on newer issues for the follow-up with working group who handled OCV community tool.
Regularly reviewed Open CDISC Validator Reports & finally documented for submission.
Helped TDMs with final submission in compliance to IG, FDA’s Technical Rejection Criteria, FDA Business Rules, Open CDISC Validator reports (OCV) – Errors and Warnings.
Validated aCRF annotations for multiple trials.
Created and validated listings using programs and edit checks.
Clinical DM SAS Programmer-I
Client: Celgene-Summit, NJ - Work Site: Alpha Stats (CRO) Plainfield, NJ (Jan 2013 - Jun 2015)
Wrote SAS programs for creating listings and tables.
Performed data manipulation in SAS (drop/keep variables, sort, merge, transpose, concatenate / join files, etc. proc GLM, proc Freq, proc Means, proc Summary, proc ANOVA, proc Univariate, proc Corr, proc Report, proc Contents, proc T-test etc).
Created reports using SAS/BASE, SAS/ODS, SAS/STAT and Excel.
Generated PDF, RTF files for the produced data listings, summary tables and reports for interim final analysis.
Enhancing reports by using global statements, added Labels, Formats, Subset, Re-grouping observations, directed output to external files using Proc Export.
Producing summary reports using Proc Freq, Proc Means and Proc Report using SAS/Graph: Created Bar Charts, Line graphs, Scatter Plots, Survival Plot using Proc Life-test.
Q’Ced Patient Profile, Prepared Excel Sheets for the Discrepancies noticed& fixed SAS Programs as per company specifications for Multiple Cancer Studies simultaneously by checking/reviewing Table of Contents, Titles, Paginations, Raw Data, Templates, Figures, CRF, SAP, SOP and Company Specifications.
Created Tables &Listing Reports - Subject Demographics, Adverse event, Concomitant Medications, Prior Medications, Laboratory (Urinalysis, Chemistry, and Hematology), Vital Signs, Medical History, Subject Disposition by Treatment, Weight Loss and Patient Pain Relief Rating Scale etc.
Developed numerous ad hoc SAS programs to create summaries and listings.
Validate Tables, Listings and Graphs by performing QC (Quality Check) extensively on tasks performed by other team members as per the specifications provided.
Performed extensively Mapping Rave Extracts study– Post-Processing specifications template by reviewing Post-Processing guide for Rave Extracts, Annotated CRF, Raw datasets, Comparison of modified data with the old data, finding duplicate records and inaccurate attributes and created Issue logs on discrepancies.
Performed extensively Validated Annotated aCRF (Case Report Form) and Execution of Company’s timely specifications before final deliverables and reported to the manager.
Participated in regular weekly meetings for timelines and other study related SOPs.
Junior SAS Programmer
Alpha Stats Inc (CRO) Plainfield, NJ (Mar2011 - Dec 2012)
Worked on validating tables, listings, graphs (TLG’s).
Generated analysis data sets from the raw data, based on the requirement specifications given by the statistician.
Created SAS customized reports using Proc report, Proc summary, Proc means, Proc freq.
Validated derived datasets, tables and listings by parallel programming as well as manually.
Performed data conversion, data derivations and provided data management support for various clinical studies.
Program data edit checks to facilitate Data Management’s data cleaning activities.
Participated in preparation of recommendations for revision, changes in data quality review.
Reviewed the Protocol, CRF and SAP for consistency with study objectives.
Experience in qc’ing data in RAVE for multiple studies as per SOP by manual review.
Maintained Validation QC Checklists for derived datasets and TLF.
Assisted in preparation of define doc, XPT files, annotate CRF for NDA submissions.
Involved in CRF (Case Report Form) annotations that represent the names of raw datasets and their corresponding variables in the raw datasets.
Worked on assigning medical codes using MedDRA dictionary.
CERTIFICATIONS
Certificate of Completion in SAS Programming Analysis.
Certified SAS Clinical Trials Programming.
Certified SAS Base Programming.
Certified Clinical Research and Drug Safety / Monitoring (CRA).
Certified RDC basic Training perspective to Clinical Research Associates.
Certified CDISC-SDTM-001A Study Data Tabulation Model.
Certified CDISC-SDTM-007A Controlled Terminology.
Certified CDISC-SDTM-018A Conformance, Validation & FDA.
Certified basic SDTM Training, ICH-GCP guidelines, Drug Safety and O*C TMS.
Diploma in Advanced Software Technology (e-DAST).
EDUCATION & TRAINING
AVTech Institute of Technology - South Plainfield, NJ SAS (Advanced programming tools), CRA-Clinical Research and Drug Safety. Bachelor Degree: English, Economics-Hyderabad, India.
E-commerce - CMC, Panipat. (India) - Advanced Diploma in Software Technology included C, C+, VB
Bachelors Degree - Osmania University.
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