SUMMARY

SAS Base Certified Programmer with around 10 years of experience supporting Statistical programming and experience in analysis, design, development, testing and implementation of clinical trial projects (I, II, III) in projects in CRO and pharmaceuticals industries.

Strong understanding of CDISC SDTM (versions 3.1.2, 3.1.3, 3.2) and ADaM (versions 2.0 / 2.1) models and experience in converting raw data to CDISC SDTM and SDTM to ADaM standards.

Experience in Cardiovascular, Respiratory, Pain Management, Immunology, and Oncology Therapeutic areas.

Experience in creating, validating, and executing various tables, listings, and graphs to assist the Statisticians, with respect to statistical analysis plan (SAP), Standard operating procedures (SOP's) and department guidelines.

Experience in Pooling the SDTM data, Analysis datasets creation and TFLs generation for CNS and Oncology ISS/ ISE and involved generating electronic deliverables & submissions for Integrated Summaries (ISE/ISS).

Good working knowledge of FDA, and GCP regulations and guidelines and hands on experience in implementing CDISC/SDTM standards and Define.xml, along with efficacy.

Developed and used SAS MACROS programs and modified existing SAS programs to make them portable as well as consistency of results.

PROFESSIONAL EXPERIENCE

Battelle, New Jersey, NJ Sept 2020 – Present

Sr. Statistical Programmer

Develop SAS programs to provide complex data review listings/reports to support different functional groups in the Oncology area.

Program data review checks as necessary to facilitate data cleaning activities.

Modify existing SAS programs using SAS macro variables to improve the ease, speed, and consistency of the results.

Provide statistical programming support in the project specific programming of tables, listings, and figures.

Prepare / review protocol documents, case report forms, annotated CRF, and statistical analysis plans for clinical trials.

Implement CDISC SDTM & ADAM standards for data by creating specifications with datasets.

Reuse statistical programs used in creating analysis datasets, tables, listings, and figures based on provided specifications - Annotated CRF, derived dataset specifications and Statistical Analysis Plan.

Create TLFs based on pooled datasets (ISS and ISE) and worked on integrated studies for the clinical Safety and Efficacy reporting updates.

Astra Zeneca, New York, NY Aug 2019 – July 2020

Sr. Statistical Programmer

Studied, evaluated, and worked with Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) data sets.

Worked on Tables Figures and Listings (TFLs), Pharmacokinetics/pharmacodynamics data preparation and analysis.

Worked on Office of Scientific Investigations (OSI) data sets and listings, manipulate and analyze adjudicated data.

Contributed to and/or lead aspects of the provision of technical consulting expertise to external partners in relation to the specification and delivery of the SDTM and RDB databases by these partners.

Provided support to and/or lead aspects of the regulatory submissions including specification and delivery of overview databases, outputs, and response to regulatory questions.

Contributed to the development of best practice to improve quality, efficiency, and effectiveness.

DOC’s/ICON plc, New York, NY Aug 2016 – July 2019

Sr. Statistical Programmer

Performed SAS programming analysis with clinical trials data for Phases I, II and III Trials in different studies.

Created TLGs based on pooled datasets for ISS and ISE and pooled the new ongoing studies for monthly datacuts to the integrated studies for the clinical Safety and Efficacy reporting updates to clinical teams.

Validated analysis datasets, listings, tables, and other ad-hoc queries generated by peers.

Performed Data Analysis and Data Validation for Tables, Listings and Graphs listed as per Programming Index SOP’s

Created/Mapped Specifications referring to the a-CRF, Study Protocol and raw data, simultaneously developed/validated legacy data into different CDISC SDTM domains.

Created RTF and PDF formatted ad hoc reports using SAS /ODS for presentation and further analysis.

Provided data in SAS Transport files and other appropriate deliverables and documentation for regulatory submissions.

Validated and developed analysis on datasets as per ADaM 2.1 standards, tables, listings, and graphs as per specifications and mockups.

Vericel, Cambridge MA Jan 2014 – May 2016

Statistical Programmer / Analyst

Coordinated in various PK analysis studies like Dose response, Dose Linearity, Bio Equivalence etc., in mapping, analysis and reporting of PC and PP data.

Involved in writing specifications for SDTM Standards following CDISC guidelines.

Prepared analyses on Datasets from excel files using Import Techniques for PK analysis.

Wrote new specifications and verified already written specifications for the Analysis datasets.

IQVIA (Previously Quintiles), Durham NC Jan 2011 – Dec 2013

Statistical Programmer

Worked as a lead programmer on two studies Phase 2 and Phase 3 clinical trials and set up study level programming environment.

Worked on different Therapeutic areas (and worked on mapping SDTM and ADaM Datasets from Raw data).

Created analysis datasets and tables for Integrated Summary of Safety (ISS).

Wrote many department, product, and study-level macros and utilities.

Involved in validating tables, listings and figures of various projects using mock shells.

Performed processing and post processing of DDT and wrote various complex macros.

TECHNICAL SUMMARY

Statistical Software: SAS 9.3/9.2/9.2 SAS EG, SAS/STAT, SAS/MACROS, SAS/GRAPH, SAS/SQL, SAS/ODS

Operating System: Windows 98-2003, 2007/NT/XP/VISTA, UNIX

Systems & software experience: SAS, MS Office, SQL, and PL SQL

EDUCATION

SAS Certified Base Programmer for SAS 9-(Certificate Serial Number: HHF1D5G1BBV41BCS, 16Mar2019)

Hofstra University 2002 – 2004

Master’s in Business Administration Hempstead, NY

Indian Institute of Technology, Madras 1996 – 2000

B. Tech in Chemical Engineering Chennai, India

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