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Data Professional Experience

Location:
Edison, New Jersey, 08817, United States
Posted:
November 27, 2017

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Resume:

Name: Anjali Sharma

Cell: 201-***-****

Email id: ac3hzq@r.postjobfree.com

Summary

A Certified SAS Programmer with over 6 years of working experience in SAS applications for Clinical Research and Analysis. Experienced working with Pharmaceutical companies and CROs.

In depth experience and knowledge in various SAS products such as BASE /SAS, SAS /MACROS, SAS/STAT, SAS/ACCESS, SAS/SQL in Windows and UNIX environments.

Worked extensively by using base/SAS, SAS/macro, SAS procedures(proc sort, proc sql, proc transpose ) to output SDTM and ADAM datasets compliance with CDISC SDTM implementation guide 3.1.3 and ADAM ig v1.0 .

Great knowledge and understanding of clinical trials study designs, study protocols, statistical analysis plans, (SAP), case report form (CRF/eCRF), annotated case report forms and company Standard Operating procedures (SOP).

Generated TLFs and reports(.rtf,.pdf) by using PROC report, ODS and SAS macros, PROC/STATS.

Experience and expertise in working for different therapeutic areas like Oncology, diabetic, neuroscience, autoimmune.

Worked for integrated summery of safety and efficacy datasets (ISS,ISE) at submission level.

Have great experience and knowledge of validation of datasets by using PROC FREQ,PROC COMPARE, PROC CONTENTS and by using parallel programming and pinacle21.

Possess strong ability to quickly adapt to new applications and platforms. Experience in interacting with clients, multiple user groups and managing development teams.

Environment

SAS 9.2, SAS 9.4, SAS Enterprise Guide 7.1

Certifications/Licenses

SAS Certified Base Programmer for SAS 9

Educational Details

Completed Base SAS Certification

MBA, Banasthali Vidyapeeth(University),Banasthali, India

Bachelor of Science in Chemistry, IGNOU, India.

Professional Experience

Brightech International, LLC

SAS Programmer II

Somerset, New Jersey (onsite)

September 2016 – Present

Generate tables, listings, graphs and patients’ profiles, Protocol Deviations and CTC AE Summary Reports using SAS for number of studies

Project team member for more than ten studies for CDISC mapping & validation

Validate the data sets and comparing the results to that of source programmer output

Knowledge of database, SQL, CRF-Annotation, SAP, specifications, SDTM IG3.1.3 ADAM IG v1.0 with respect to various therapeutic areas like oncology, autoimmune .

Created ADaM compliant Analysis Datasets with derived variables (including efficacy datasets like ADTTE, ADRS etc and safety datasets like ADAE, ADLB etc) according to analysis datasets specifications, RECIST1.1 criteria and SAP (Statistical Analysis Plan).

Able to independently design, code, and debug simple to complex SAS programs in a timely manner.

Translates requests for simple to complex statistical analyses, data preparation, data manipulation, and reporting tools into SAS programs and macros.

Independently creates analysis datasets, statistical tables, summaries, figures and listings for oncology studies going on for Breast cancer, ovarian cancer and prostate cancer, Diabetic study, Neuroscience (drug for Alzheimer’s disease) and autoimmune drug study.

Independently creates CDISC standard datasets (SDTM and ADAM) i.e DM, CM, MH, AE, EX, DA, PR, VS, EG,LB,TU,TR,RS,QS, ADSL, ADAE, ADLB, ADEX, ADRS, ADTTE etc. for Breast cancer and prostate cancer and ADLDIB, ADTTE etc for autoimmune disease . Also generated suppdatasets and relrec dataset for the mentioned study.

Generated TLFs and reports(.rtf,.pdf) by using PROC report, ODS and SAS macros, ANOVA, ANCOVA, PROC MIXED, PROC LIFETEST.

Participates in the validation of SAS programs and analysis datasets.

Maintains documentation for SAS programs.

Statistics and Data Corporation (SDC)

Statistical Programmer (Remote)

March 2014 – September 2016

Contributed in creating SDTM specification.

Created CDISC compliant SDTM datasets DM, CM, MH, AE, EX, DA, PR, VS, EG,LB,TU,TR,RS,QS, etc. for all assigned new and ongoing studies and validated them for Phase I- Phase III for breast cancer drug study and also for medical devices.

Created ADaM compliant Analysis Datasets with derived variables (including efficacy datasets like ADTTE, ADRS etc and safety datasets like ADAE, ADLB etc) according to analysis datasets specifications, RECIST criteria and SAP (Statistical Analysis Plan).

Provided statistical programming and validation support for analysis datasets, statistical tables, figures, listings.

Reviewed Protocol, Statistical Analysis Plan (SAP), and shells for tables, listings and figures for projects. Partnered with project statistician and programming team on the implementation of the statistical analysis.

Performed statistical analysis using SAS/STAT Procedures like FREQ, MEANS, SUMMARY, UNIVARIATE, LIFETEST etc. with the models provided by the statisticians.

Produced KM plots of PFS and OS using procedures like GPLOT, GCHART, LIFETEST, PHREG and annotation facility.

Created tables, listings and generated reports and graphs for phase II - III studies for oncology studies ongoing.

Created edit checks for data manipulation.

Created ad hoc reports upon request of biostatistician.

Created Macros to improve ease and speed of modifications as well as consistency of results.

Grunenthal Pharmaceuticals

SAS Programmer (onsite)

July 2012 – February 2014

Annotated CRF and developed programming specifications for SDTM as per SDTM implementation guide, protocol and SAP by interacting with statisticians.

Mapped raw data to CDISC specific domains and created ADaM datasets like DM, CM, MH, AE, EX, DA, PR, VS, EG,LB,TU,TR,RS,QS, ADSL, ADAE, ADLB, ADEX, ADRS, ADTTE etc. for ovarian cancer drug study form Phase I- Phase III.

Worked with MedDRA and WHODrug dictionaries extensively and developed macros to get data from these dictionaries.

Performed statistical analyses and produced Summary tables, figures and listings by using statistical and reporting procedures for ISS and ISE.

Enhanced reports through the use of user-defined style templates, titles, footnotes and SAS System reporting options.

Used Proc SQL extensively for selecting specific data and generating ad-hoc reports.

Created reports in the style format (RTF, PDF and HTML) using SAS/ODS.

Validated SDTM and analysis datasets, tables, listings and figures by Parallel programming to ensure that output meets quality standards and project requirements

Experienced in supporting multiple projects under deadlines often with competing priorities and complexities by applying critical thinking, problem solving, and decision making skills to optimize solutions.



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