Clinical Data Us Citizen

Sarma Pappu

Status: US Citizen

Cell # 732-***-****

********@*******.***

** ******** *****, **********, ** 08854

SUMMARY:

Senior Statistical Programmer over 20 years of experience supporting Phase I-IV clinical trials for various therapeutics areas. Experience in Registries and Post Marketing Analysis in the fields of Pharma, CRO and Healthcare industries.

Possess good working knowledge on the CDISC standards. Experience in reviewing the specs for SDTM and ADaM.

Experience in generation of SDTM and ADaM datasets as per dataset specifications.

Possess good experience in the creation of integrated summaries (ISS/ISE).

Possess good knowledge of processing of clinical data.

Experience in study report, regulartory submission and Ad hoc and /post adhoc analysis

Maintain programming documents like study tracker, program_log, title work sheet

Always meet the time lines for the deliverables with accurate outputs

Has excellent communication skills, collaboration skills, and people skills.

Quick learner.

PROFESSIONAL EXPERIENCE:

May 2015 – June 2023

Cytel, Inc., Waltham, MA

Senior Statistical Programmer, FSP (Biogen Pharmaceutical, Cambridge, MA)

Worked on the SMA (Spinal Muscular Atrophy) studies.

Created SDTM and ADaM datasets as per study dataset specifications for Phase II and Phase III studies. Created the analysis datasets for final reports, prepared abstracts, posters, manuscripts, and other clinical publications as per the timelines.

Generated TLGs.

Acted as a team player by supporting the team with sharing of tasks on an ad hoc basis.

Was accountable for ensuring that the regulatory requirements are met through validation/compliance activities.

Maintained program(s) documentation.

June 2011-May 2015

Smith Hanley Consulting Group, Edison, NJ

Biostats and Programming

Sr SAS Clinical Programmer/Analyst (PharmaNet/13)

Worked on several Phase I, II, and Phase III studies for the creation of SDTM, ADaM datasets as per CDISC standards within the Asthma, Diabetes, Infectious Disease, Cardiovascular, and Oncology Therapeutic Areas. Was responsible for programming.

Generated TLGs.

Validated and/or performed quality control checks on programs.

Maintained Statistical Programming project documentation.

August 2009- May 2011

Smith Hanley Consulting Group, Hopewell, NJ

Global Biometrics Sciences Division

SAS Clinical Programmer/Analyst (Bristol Myers Squibb)

Worked on several Phase II studies for the creation of SDTM and ADaM datasets as per CDISC standards within the Cardiovascular Therapeutic Area.

Generated TLGs.

Validated and/or performed quality control checks on programs

Maintained Statistical Programming project documentation

July 2006 - July 2009

Smith Hanley Consulting Group, Bridgewater, NJ

Biostatistics and Programming

SAS/ Clinical Programmer/Analyst (Sanofi-Aventis)

•Worked on the Phase I, II and III clinical projects within the Oncology TA.

•Created SDTM and ADaM datasets for the Safety (ISS) and Efficacy (ISE) analysis.

•Performed Efficacy Analysis for Primary and Secondary Endpoints for Survival Analysis.

•Developed SAS Macros to generate TLGs for Safety and Efficacy and create appendices for CSR.

•Validated datasets and TLGs.

•Collaborated very closely with the Statisticians, Data Management, and other team members.

June 2004 - July 2006

Smith Hanley Consulting Group, Wallingford, CT

Global Biometrics Sciences Division, Pharmaceutical Research institute

SAS/Statistical Programmer (Briston-Myers Squibb)

•Prepared SDTM SAS datasets from raw data for electronic submission of Phase l, II, III clinical projects.

•Generated TLGs.

•Validated the programs written by other programmers.

•Collaborated closely with Managers, Team Members, Statisticians and other personnel in the team for delivering in a timely manner.

•Prepared the documentation of processes used for future reference.

October 2003 - May 2004

Smith Hanley Consulting Group, Cambridge, MA

Bio Medical and Data Management

SAS/ Statistical Programmer/Analyst (Alkermes)

•Worked on Phase I, Phase II, and Phase III clinical projects.

•Extracted data from the Clinical Database for the creation of SAS Raw Datasets

•Created SAS datasets from raw data.

•Generated TLGs.

•Validated the clinical Data and TLGs.

•Collaborated closely with the Data Management Team, Clinical Development Team, and Statisticians for the creation of the deliverables.

July 2002 - October 2003

Smith Hanley Consulting Group, Cambridge, MA

Registry Programming Group, Bio Medical Operations

SAS/ Statistical Programmer/ Analyst (Genzyme Co.)

Worked on the Rare Disease Registries for Gaucher, Fabry diseases, and Cerezyme Clinical Studies.

Generated Analysis Datasets and CRT Datasets for statisticians.

Generated TLGs for Clinical Studies.

Created Standard Reports such as Site Report, Country Report, and Status Report.

Ensured Quality Control of programming and reviewed SAS programs.

Maintained and updated SAS Programming documentation.

September 2001 -June 2002

Merk & Co., West Point, PA

SAS Programmer/ Analyst

Validated the raw data and prepared input datasets using SAS/Base Techniques.

Created TLGs as per Statistical Analysis Plan.

Documented the processes accordingly for future reference.

EDUCATION:

1.Diploma in SAS "Macro Language" from SAS Institute, USA

2.Post Graduate Diploma in Computer Sciences, Indira Gandhi National University, Hyderabad, India. Computer Applications

3.Post Graduate Diploma in Computer Sciences, Annamalai University, Chidambaram, Tamil Nadu, India.

4.Bachelor of Science, Andhra University, Andhra Pradesh, India.

COMPUTER SKILLS:

Language: SAS/Base, SAS/Macros, SAS/Graph, SAS/Stat, SAS/OR, SAS/Access, SAS/Connect, SAS/SQL, SAS/ODS, Splus

Operating Systems: UNIX, MYS, VMS, Windows & NT

Reporting Tool: Business Objects 5. I.

Database: Oracle 8i, PL/SQL, SQL MS-Access, lnformix, DB2, dBase

Graphics & Spreadsheet: PowerPoint, Excel

Unix, Windows XP, SAS v9.0

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