sas programmer

SUMMARY:

SAS Programmer with *+ years of experience in Statistical Analysis System (SAS) programming for developing and implementing applications in Pharmaceutical and Clinical research.

Developed SAS programs for various analyses in Phases II and III of Clinical Trials

Profound knowledge on the following CDISC standards for the submissions: SDTM Version 1.1 to 1.4, SDTM Implementation Guide Version 3.1.1 to 3.2, Analysis Data Model Version 2.0,, FDA Code of Federal Regulations (21CFR part11) and other Regulatory Submissions.

Created study mapping specifications and also experienced in receiving, extracting data, transforming to SDTM and defining controlled terminology.

Worked on special purpose domains and general purpose domains.

Experienced in the creation of transport (.XPT) files using proc copy and generated report using Open CDISC validator and addressing the issues.

Generated Define.XML document and also reviewed Define.PDF document to ensure everything is appropriate as per the standards.

Created several ADAM datasets in accordance to the specifications and experienced in creating ADSL, ADAE, ADTTE and BDS structured domains.

Experience in SAS/Base, SAS/Macros, SAS/SQL, SAS/Graph, SAS/Stat, SAS /ODS, SAS/Access.

Experience in wide range of therapeutic areas like Oncology, Diabetology and CNS disorders etc.,

Generated Reports, Tables, Listings, and Graphs as per company standards and in compliance with FDA and other regulatory compliance.

Performed various QC/ Validations for datasets and TLG’s.

Good knowledge of Statistical Analysis Plan, Standard Operating Procedures, Protocols of clinical trials and different study populations.

Expertise in developing SDTM specifications, good knowledge about eSHARE library and used it to access the CDISC standards.

Sound knowledge on generating report using Open CDISC validator Pinnacle 21 In addressing the issues.

Extensive experience in performing different operations on SAS data sets of any size like Sorting, Merging, Concatenating, and Interleaving.

Proficiency in importing external files and producing customized reports using SAS procedures.

Experience with transforming data in various formats (excel, CSV, ASCII) into SAS datasets.

Experience in joining, merging and extracting data from various datasets using SAS data steps and PROC SQL.

Involved in mapping datasets from old studies to comply with new studies for the creation of ISS datasets

Experienced in development and validation of ISS tables and listings.

Expert in using SAS ODS to create HTML, RTF and PDF output files and Data _Null_ to generate ad hoc and customized reports.

Experience in using various procedures like PROC COMPARE, UNIVARIATE, CONTENTS, FREQ, ANOVA, GLM, LIFETEST, and GPLOT.

Highly organized, dedicated with positive attitude, self-motivated and committed in individual and in team work.

Strong Analytical skills, communication, interpersonal, & organizational skills.

Professional EXPERIENCE:

Wesnia Info Solutions Pvt Ltd, Banglore India

Mar 2012 – April 2017

Statistical programmer-II

Worked on Oncology, CNS therapeutic areas

Planning and coordinating programming, testing, and documentation of statistical programs for use in creating statistical tables, graphs, and listing summaries of clinical trial data using SAS BASE/MACROS/STAT/ SQL and SAS ODS (Output Delivery System).

Participated in review and annotation of Case Report Forms (CRF).

Created new SDTM datasets from raw data files by mapping the variables from CRF’s.

Created SDTM datasets for Special purpose domains, Suppqual, RELREC, Interventions, Events, Findings and Trial domains.

Generate Analysis datasets with derived variables as per the client specific standards and performed statistical analysis on data as per the SAP.

Worked on the creation of various flag variables such as ITTFL, SAFFL, PPROTFL, FASFL, Treatment emergent flags, Record level flag such as ITTRFL, FASRFL, BLFL, and Parameter level flags such as ITTPFL, FASPFL.

Used various missing data imputation methods such as LOCF, BOCF and WOCF.

Worked with statistician and clinical data manager to provide SAS programming in creating and analyzing the data, generating reports, TLG’s as per SAP.

Creation of Baseline summary of Demographics, Adverse Events, Serious Adverse Events summary of Labs and CM, Disposition tables etc as per the SAP.

Created tables, listings, and graphs for the purpose of clinical submissions.

Generated standard and ad-hoc reports as requested by team. Perform other duties as instructed by the statistical team.

Worked with Data Management and Study team to create various data cleaning listings to ensure the quality of data.

Involved in blinding and un-blinding the studies.

Used internal macros and written SAS macros to automate statistical Tables, Figures, and Listings production.

Involved in multiple studies at a time and interacted with Statisticians, Data manager and Clinical Associates to analyze data.

Used the ODS feature extensively for proc report to create both RTF and PDF files for Tables and Listings.

Reviewed and provided feedback on various clinical trials documents such as Protocol, SAP, CRF, edit checks etc.

Validated co-programmer’s Analysis Datasets and Tables by independent programming.

AXIS Clinical LTD, Hyderabad, India

May 2010 –Feb 2012

Associate Statistical Programmer

Involved in the support of Phase II, and III clinical trials and worked majorly on Diabetology, CVS

clinical trials.

Created the Analysis datasets from raw data sets, derived new variables, created flag

variables as per Specs file and with the help of other ADS Concepts

Developed safety and general purpose tables like Adverse Events table, Disposition table, Demographics Baseline Characteristics and Concomitant Medication tables etc

as per the mock-shells.

Worked in the team preparing Integrated Summaries of Efficacy (ISE) and Safety (ISS) reports.

Modified existing data sets by using the statements like SET, MERGE, UPDATE, Transpose and Conditional statements.

Carried out data extraction and data manipulation using PROC SQL, PROC SORT, and PROC REPORT as per requirements.

Made modifications in the existing SAS programs.

Review of macros/codes of the Load System.

SKILLS:

SAS Modules: SAS (BASE, STAT, GRAPH, SQL, MACROS, ODS)

Packages: MS Office (MS Access, MS Excel, MS PowerPoint, MS Word)

Operating Systems: Windows 95/2000/XP, UNIX

Programming: SAS, SQL

EDUCATION:

Bachelor of Pharmacy from Sri Padmavati University

Master of Business Administration from Osmania University

Certification:

SAS Certified Base Programmer for SAS 9

SAS Certified Advanced Programmer for SAS 9

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