Sarma Pappu

Status: US Citizen

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

adz7e6@r.postjobfree.com

** ******** *****, **********, ** 08855

SUMMARY: Senior Statistical Programmer with 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.

PROFESSIONAL EXPERIENCE:

April 2021 – Current:

Cytel, Inc., Waltham, MA

Senior Statistical Programmer, FSP (UCB Pharma)

Worked in Biostatistics and programming division on BIMEKIZUMAB (BKZ) product:

BKZ is used as a treatment for the patients who suffer the Rheumatic Arthritis or Psoriatic Arthritis.

As Senior Statistical Programmer actively involved in:

Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), and the Integrated Summary of Immunogenicity (ISI) in support of regulatory submission for phase I-II-III studies.

My major role was to create ADaM datasets and generate Tables/Listings/Figures for the regulatory submission as per dataset Specs and TLF shells.

There are 5 pools created in Integrated ADaM datasets

This includes submissions to:

1.The US Food and Drug Administration (FDA),

2.The European Medicines Agency (EMA)

3. The Pharmaceuticals and Medical Devices Agency (PMDA).

Actively involved in creating BIMO (Bio Research Monitoring) listings of 2 studies each study consists of more than 100 sites and 17 safety listings and 11 efficacy listings. This is a huge project that I lead with my UCB Manager’s guidance. All listings were bundled after the statistician passed them.

Involved in creation of pooling of efficacy datasets of different studies as per specifications.

May 2015 – March 2021

Cytel, Inc., Waltham, MA

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

Worked in Biostat and Programming group on SMA (spinal muscular atrophy).

•Create SDTM and ADaM datasets as per study dataset specifications

•Generate Tables/Listings/Figures as per SAP and TOC

•Worked in Phase II and Phase III studies

•Assist the Statistical Programming staff and Biostatistical Staff to create tables, data listings, graphs and analysis for final reports, abstracts, posters, manuscripts and other clinical publications.

•Assist in establishing standardized programming procedures and work instructions.

•Meet the study timelines and also support the team in sharing the tasks

•Involve in any ad hoc tasks that are assigned.

•Ensure that the regulatory requirements are met through validation/compliance activities.

•Maintain program(s) documentation.

•Attend meetings and trainings arranged by Manager and other study teams

June 2011-May 2015

Smith Hanley Consulting Group, Edison, NJ

Sr SAS Clinical Programmer/Analyst (PharmaNet/13)

Phase I, Phase II and Phase III studies

Worked in Biostat and Programming unit as SAS Clinical Programmer/Analyst in involving several studies in Asthma, Diabetes, Infectious Disease, Cardiovascular and Oncology Therapeutic Areas.

•Having good knowledge in CDISC standard in generation of SDTM and ADaM datasets.

•Experience in integrated studies (ISS/ISE).

•Wrote and executed statistical programs designed to analyze clinical trial data, including any or all of the following: SDTM, ADaM datasets as per CDISC standards, tables, listings, and graphs

•Validated and/or performed quality control checks on programs

•Maintained Statistical Programming project documentation

August 2009- May 2011

Smith Hanley Consulting Group, Hopewell, NJ

SAS Clinical Programmer/Analyst (Bristol Myers Squibb)

Phase II studies

Working in Global Biometrics Sciences Division as Statistical Programmer involving in Clinical Trial Studies on Oncology, Cardiovascular areas in

•Preparation of SDTM/ADaM datasets as per CDISC standards. Generation of

Tables, Listings and Figures as per study requirements.

•Also performed validation of Datasets, TLFs.

•Fulfilled the ad-hoc programming requests.

July 2006 - July 2009

Smith Hanley Consulting Group, Bridgewater, NJ SAS/ Clinical Programmer/Analyst (Sanofi-Aventis)

•Working in Biostatistics and Programming department involve in Oncology studies of Phase I, II and III.

•Active involvement in processing of Clin Trial and Oracle Clinical Trial studies.

•Using of CDISC v3.0 standards, creation of SDTM and ADaM datasets for Safety (ISS) and Efficacy (ISE) analysis.

•Safety analysis for different domains such as Demography, Concomitant Medication, Clinical Laboratory Data, Vital Signs, ECG and other study specific domains.

•Extensive use of Base SAS procedures like Proc Sort, Proc Means, Proc Univariate,

Proc Freq, Proc Transpose, Proc Append, Proc Report, Proc Tabulate.

•Extensive use of Base SAS data step techniques such as Merge, Keep, Drop etc.

•Use of SAS/Graph (Proc gplot, Proc greplay)

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

•Extensive use of SAS/Stat Procedures such as Proc Lifetest, Proc Lifereg, Proc Phreg etc. For estimating and comparing survival curves extensively use of Kaplan-Meir (KM) method.

•Generation of TLGs for Safety and Efficacy and create appendices for CSR.

•Develop of SAS Macros for Safety and Efficacy analysis.

•Validation of datasets and TLGs. Run edit checks and other Adhoc Reports

•Coordinate the SAS programs, data spec document, datasets and outputs from CRO.

•Close interaction with Statisticians, Data Management, Department Function, System Support and other team members

•Extensive use of department tools (CBWCA/WlSE) for SAS processing.

•Attend training, provide by department functions on SOP and department tools.

•Any other task assigned by Manager and other members

•Unix, Windows XP, SAS v9.0

•Participated in presentation on:

•Processing of Manual ECG data

•Participated the processing of Oracle Clinical data in professional conferences and meetings in Biostatistics and Programming, Bridgewater Site.

July 2004 - July 2006

Smith Hanley Consulting Group, Wallingford, CT SAS/Statistical Programmer (Briston-Myers Squibb)

Working in BMS (Global Biometrics Sciences Division, Pharmaceutical Research institute, Wallingford, CT) as Statistical Programmer involving in Clinical Trial Studies.

•Active participation in Electronic Submission datasets for Clinical Phase l, 11, llI studies. Written several dynamic SAS programs/macros to validate the datasets as per the specifications for eSUB.

•Generation of tables, listings, figures for Several Clinical Studies

•Validation of programs written by other programmers

•Regular interaction with Managers, Team Members, Statisticians and other personnel in the team.

•Met timelines for the tasks assigned.

•Document the task process for future reference.

•Unix, NT, SAS, PC SAS, SAS JMP

October 2003 - May 2004

Smith Hanley Consulting Group, Cambridge, MA SAS/ Statistical Programmer/Analyst (Alkermes)

Working in Bio Medical and Data Management as Statistical Programmer involving in Phase I, Phase II and Phase III clinical studies.

•Extracting data from Clinical Database and creating SAS Raw Datasets

•Normalization of data as per CDISC specifications

•Generating Tables, Listings and Figures for Clinical Studies

•Data validation.

•Interaction with Data Management Personnel, Clinical Development Personnel and Statisticians

•Any other task assigned by Manager, Statistical Programming

July 2002 - October 2003

Smith Hanley Consulting Group, Cambridge, MA

SAS/ Statistical Programmer/ Analyst (Genzyme Co.)

Worked in Registry Programming Group, Bio Medical Operations involved in Registries for Gaucher, Fabry diseases and Cerezyme Clinical Studies

Generating Tables, Listings and Figures for Clinical Studies

Writing SAS Programs /Macros for Ad hoc Reports, Data Requests, Manuscripts, Abstracts, Analyses and Regulatory Reports

Running Standard Reports such as Site Report, Country Report, Status Report upon request

Generate Analysis Datasets and CRT Datasets for statisticians

Quality Control of programming and review of SAS programs

Maintain and update SAS Programming Documentation

Any other tasks assigned by the Manager.

Attending Statistical Programmers weekly meeting.

September 2001 -June 2002

Merk & Co., West Point, PA

SAS Programmer/ Analyst

•Extracted data is validated and prepared input data set using SAS/Base Techniques.

•Created Tables, Listings and Figures as per Statistical Analysis Plan for Clinical Studies.

•The process was documented accordingly for future reference.

EDUCATION:

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

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

Computer Applications

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

Computer Applications

Bachelor of Science, Andhra University, Andhra Pradesh, India Biological Sciences

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

•Programming derived datasets (experience with CDISC SDTM and ADaM), tables, listing and figures for Phase I-III trials; performing validation

•Writing dataset specifications, programming plans and other required documents

•Pooling studies and creating ISS, ISE

•Helping with submission and with answering FDA/EMEA questions, adhoc requests

•Providing input into (e)CRF, SAP, reviewing outputs and specifications

•Collaboration with Statistician and Data Manager

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