Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Madhu Sunku

Summary

Around 13+ Years of experience in SAS Programming. Certified Base and Advanced SAS programmer. Strong ADaM Implementation experience and creation of ADaM data specifications and data definition tables for eCTD documentation in Phases 1-4 of clinical trials Extensive experience as project lead in multiple therapeutic areas including Oncology,Gastroenterology, Neuroscience (Dementia), Respiratory, and Cardiovascular disorders. Experienced as lead statistical programmer and support programmer on clinical studies, integrated. Summaries, and respond to requests from study reporting authorities. Very thorough and experienced in reviewing statistical analysis plans, annotated CRFs, programming. specifications, and provide comments to the respective functions. Experienced in providing feedback on standard operating procedures for Statistical Programming. Worked closely with other functional groups such as Senior Statisticians, Data Managers, and Clinical Managers and SDTM standards team. Experienced in ISS and ISE reporting. Expertise in attention to detail and checking data for anomalies. Proven skills in Quality Assurance (QA), problem solving, data archival, data extraction from Oracle, ad-hoc reporting, and coding, utilizing SAS on both UNIX and Windows platforms. Positive attitude and the ability to work well with others and demonstrated initiative and motivation. Excellent in communication and mentoring skills.

Overview

18
18
years of professional experience
1
1
Certification

Work History

Sr Statistical Programmer

ICON
10.2019 - Current
  • Working as Sr Statistical Programmer for standards team
  • Creation and validation of standard macros for ADaM Datasets, tables, listings and graphs.
  • Statistical programming of studies (J&J) and responsible for all the deliverable TLF outputs assigned.
  • Working as QC programmer for standard macros created related to ADaM/TLFs in different therapeutic areas.
  • (Client: J&J Pharma May 2022 to till date)

Safety Statistical Programmer

ICON
10.2019 - Current
  • Working as Statistical Programmer for the oncology studies in Kite systems.
  • Creation and validation of SDTM, ADaM Datasets, tables, listings and graphs using these datasets.
  • Statistical programming of studies (Kite) and responsible for all the deliverable TLF outputs assigned.
  • Working as Programmer and QC programmer regarding development of analysis datasets and TLFs in studies related to different therapeutic areas.
  • (Client: Kite Pharma. August 2019 to October 2021)

Sr. Statistical Programmer

Parexel International
10.2014 - 08.2019
  • Working as Study lead for the phase I and II studies in Gsk systems.
  • Coordinating with client i.e. study POC and study statisticians both PXL and client statisticians.
  • Coordinating with offshore teams to clarify the programmer’s questions and data issues.
  • Creation and validation of SDTM, ADaM Datasets, tables, listings, and graphs using these datasets.
  • Statistical programming of studies (GSK) and responsible for all the deliverable TLF outputs.
  • Worked as Programmer and QC programmer regarding development of analysis datasets and TLFs in studies related to different therapeutic areas.
  • Planned and managed statistical analysis projects and performed all the Trial level statistical programming activities in all phases of the studies.
  • Worked as reviewer to deliver study with first time quality on timely manner as per SAC date.
  • Involved in study archiving and on Open CDISC validator.
  • Expertise in creation of reusable macros for validation of SDTM, ADaM Datasets, tables, listings and graphs using these datasets
  • Worked closely with Statisticians/Data Managers to provide SAS programming to analyze the Clinical Trial Data, generate outputs as per RAP standards, creation of datasets, and documentation of mapping.
  • Created Define.xml and packaging study documents for NDA submission for CDISC study.
  • Experience in Clinical Data Analysis, Clinical Data migration, Generating Analysis datasets, Tables, Listings
  • Graphs, Validations, and Documentation
  • Successfully represented the company in National and Regional level conferences for Presentation of Application development.
  • Listings and Reconciliation Reports for the Data Management
  • (Client: GSK October 2014 to August 2019)
  • (Employer: Sprys technologies)

Sr.SAS Programmer

Cognizant Technologies. Ltd.
11.2009 - 10.2014
  • Create ADaM datasets from SDTM datasets, writing the specifications to create reports - tables, listings and graphs.
  • Modify existing datasets to changing specifications, addition of new variables and quality control of analysis datasets by double programming.
  • Successfully lead the team in validation of CDISC datasets creating primary and secondary efficacy tables and safety tables from CDISC datasets.
  • Involved in Gender analysis for various endpoints, support statisticians with table shell enhancements and Create tables.
  • Creation of Define. doc for NDA using SAS with Bookmarks.
  • Quality Control of tables, listings and graphs by double programming or random verification of values.
  • Effective utilization of macros for programming for efficient performance.
  • Create impromptu reports as per requirements for the Stats.
  • Created and maintained large data sets, combined data from various sources in varying formats to create SAS datasets, performed data analysis, statistical analysis, generated.
  • Environment: SAS 9.2, SAS/BASE, SAS/MACRO, SAS/SQL, SAS/STAT, SAS/CONNECT, SAS/GRAPH, SAS/ODS, MS Excel, MS Visio, MS Project, Teradata, Oracle9i, UNIX, Enterprise Guide.
  • (Clients: Well care, Novartis, IMS)

SAS Developer

Tata Consultancy Services. Ltd.
12.2007 - 11.2009
  • Provided SAS Programming for tables, listings, figures based on SAP.
  • Developed and validated program for analysis data sets, safety and efficacy Reports, listings and figures, and ad-hoc requests.
  • Developed various MACROs for summary reports, listings and figures.
  • Developed reports using PROC REPORT on AE (Adverse Events) , SAE (Serious Adverse Events) and laboratory results as a part of safety measurement.
  • Created tables, listings for the collected requirement from the statisticians.
  • Set up and maintained secure and efficient statistical programming environment.
  • Developed edit check program for database management and patient profile/narrative. Report for medical writing.
  • Environment: SAS 9.1, SAS/BASE, SAS/MACRO, SAS/SQL, SAS/STAT, SAS/CONNECT, SAS/GRAPH, SAS/ODS, MS Excel.
  • (Client: Pfizer)

Education

Master of Computer Applications -

Osmania University

BSc - Computer science

SK University

Skills

  • SAS Tools: SAS/Base, SAS/Macro, SAS/SQL, SAS/Access, SAS/STAT and SAS/Graph SAS Enterprise guide
  • Operating Systems: Windows (NT/XP/2000/2003/2008 Client/Server), AIX, Red Hat Linux 56
  • Databases: MS Access 2010, MS SQL Server, Teradata, DB2, Oracle
  • Other Tools: Uc4, winCvs, Winscp, Mantis
  • Quality control processes

Certification

  • SAS Base9 Certification
  • Advanced SAS certification

Timeline

Sr Statistical Programmer

ICON
10.2019 - Current

Safety Statistical Programmer

ICON
10.2019 - Current

Sr. Statistical Programmer

Parexel International
10.2014 - 08.2019

Sr.SAS Programmer

Cognizant Technologies. Ltd.
11.2009 - 10.2014

SAS Developer

Tata Consultancy Services. Ltd.
12.2007 - 11.2009

BSc - Computer science

SK University

Master of Computer Applications -

Osmania University

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Madhu Sunku