Sas Programmer Clinical Data

Thanuja Adapaka ****************@*****.*** 636-***-****

Summary: -

Overall 8+ Years of experience and I have SAS Certified Professional having 4+years of experience as SAS Programmer in clinical domain.

Created CSR reports

Created ADaM data sets as per specifications

Created SDTM data sets from raw datasets

Extensive experience in phases I to IV of clinical trials: analyzing clinical data, creating tables, listing and graphs.

Expertized in Pharmacokinetics studies with involving in Nonmem and Winnonlin Data.

Expertized in therapeutic areas like CNS, ONCOLOGY, CVS, PAIN, IMMUNOLOGY etc.

Extensive experience in working on Efficacy endpoints with Time to Event Analysis,

ANCOVA modeling, Mixed modeling, Logistic analysis, Categorical Analysis etc.

Demonstrated proficiency in CDISC SDTM Mapping and ADaM Programming, NDA Submissions, Validation, Statistical Analysis, ISS, ISE, PK/PD process, Output Delivery System (ODS), Data Migration, Ad-Hoc Listing/Reports, SAS Data Steps, SAS Macros, Graph, Summarizing and Reporting procedures.

Considerable experience with the preparation of SAS datasets and generation of ad-hoc reports, tables, listings and graphs according to guidelines in Statistical Analysis Plan (SAP), Standard Operating Procedures (SOP) and Data Specs.

Good Experience in Statistical Analysis using SAS/STAT Procedures such as PROC FREQ, PROC MEANS, PROC UNIVARIATE, PROC SUMMARY, PROC GLM, PROC MIXED etc.

Good understanding of CRF Annotation, ICH, 21CFR part 11 guidelines, FDA regulations, WHO drug, MedDRA dictionaries and System Development Life Cycle concepts.

Experience with Data Validation, designing Edit check programs and parallel development of tables & listings for project level programs.

Expertized in analysis of Visit Windowing, Missing data handling using LOCF, BOCF, WOCF concepts and also written analysis files specifications for various therapeutic areas.

Exceptional problem-solving skills with excellent communication skills, detail oriented, organized, enthusiastic to work in a fast paced and team-oriented environment.

Technical Expertise:

SAS: Base SAS, SAS/STAT, SAS/MACROS, SAS/GRAPH, SAS/SQL, SAS/ODS, SDD, SAS EG.

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

Professional Experience: -

Sr. Clinical SAS Programmer II

Qudrant Technologies 2023- Till date

Saint Louis, Missouri.

Roles and Responsibilities: -

Leading independent studies with a team size of 6 members and drafting ADaM specifications and also creation of ADaM datasets. Also used OPEN CDISC VALIDATOR to check compliance of SDTM and ADaM datasets and cleaned the report.

Created specifications and involved in programming ADaM datasets from SDTM datasets like ADSL, ADAE, ADLB, ADDV, ADEX, ADTTE, ADPC, ADPK, ADEFF etc. and TLF

generation for multiple studies.

Interacting with Clients on various issues regarding Mapping, Analysis and conducting meetings as necessary.

Acted as a backup lead for 20 studies integration on ISS and worked collaborately with client to produce quality outputs.

Interacted with Cross functional Teams and helped them in providing programming support and also raised the issues related to the Study data.

Headed various PK/PD studies and created macros to produce the Descriptive statistics (geometric statistics) and Inferential statistics tables using PROC MIXED where subjects as random Effects.

Created Macros for ISS studies to generate Safety outputs with corresponding P Values and CI.

Programming Responsibilities:

To ensure allotted CRF annotation is done and corresponding Peer QC is done with QC comments documented on tracking tool for each work request.

Involved in preparing ISS & ISE as part of NDA for regulatory submission.

Provided full statistical programming support for: generating tables, listings, graphs, derived datasets, pooled databases for integrated analysis of efficacy and safety tables.

Worked with validation team to validate the applications compliance with 21 CFR part 11 regulations.

Used SAS Macros for generating tables and listings.

Produced safety and efficacy reports in PDF formats.

Created analysis datasets, graphs, tables and listings for High Priority requests.

Involved in QC of CDISC SDTM data sets following SDTM IG 3.1.3 and developed macros for validation process.

Sr. Clinical SAS Programmer II

Stack Nous Technologies Pvt Ltd

IQVIA 2018 - 2023

Saint Louis, Missouri.

Involved as a study/product lead programmer for specific products in early development team (Phase 1study)

ExperiencedworkingonseveralTAandSpecifictoOncologyTAPhase1 experience.

Responsible for reviewing of deliverables before submission to the client. Also created SAS datasets, tables, listings, figures by both core programming and using standard macros and always had hands on exposure of programming.

Act as SME to the team when needed. Provide hands on technical programming support as needed.

Actasinternalauditortoensureprojectcomplianceinaccordancewithinternal Quality management system

Involved in preparation of Programming specifications.

Extensive experience on all kind of submissions like DSUR, All other periodic reports,IB,E2L,Advisory,CSRsandotherpublicationslikeASCO,EHA,ESMO, ASH and US and Japan FDA regulation activities.

Validate SDTM datasets by Pinnacle2l.

Good hands-on experience on CDISC and define files review and creation. Experience on Eudra CT and CT.GOV XML files generation and review.

Responsible for quality of work delivered to client by the team.

Involved in client meetings discussing about the pipeline work, metrics, resource projection and any other issues.

Responsible for generation of timeline metrics & quality metrics and provide to client periodically.

Projecttheresourceusagefornextmonthsandgenerateatemplatetomakesure resource is optimum utilized.

Participate in organization level activities like being a part of interview panel and help when needed.

Ensureanyotheradhocrequestofprogrammingactivitiesarecompletedwithagreed timelines and quality.

Lead programming teams across one or more therapeutic areas in a global environment

Generate safety, efficacy and figures using SAS programming and reading and understanding the program specifications document

Preparing SDTM and ADaM standard SAS datasets

Generating safety tables, listings using standard client macros

Creating a CRF as per the standards and generating figures as per the required documents

Creating Programming specifications for Analysis data sets as per the CDISC standards and also for CRT datasets

Validating datasets as per client assignment specifications.

Handling Early Phase studies from end to end

Fortira Inc 2012 – 2016

Hyderabad

Understanding the CRF, SAP, Protocol

Created Tables, Listings and Graphs for FDA Submission

Communicated with client and understanding their requirement

Validated generated Tables, Listings by using SAS Programming

Understanding and working on client specific Macros

Reviewed and developed the specifications for generation of SDTM mapped datasets and Analysis Datasets

Developed SDTM, ADaM datasets from raw datasets

Actively participated in presentation of newly learnt topics in the Knowledge sharing sessions

Produced reports in PDF and RTF format by using SASODS

Writing logic Flow for assigned Tables

Workedonmacrosgivenbyclientforroundingdescriptivestatisticsandgenerating outputs

EDUCATION QUALIFICATION

Ms in Information Technology and Science, Webster University, MO USA 2024 .

MSc in Statistics from Pondicherry Central University, Pondicherry 2010-2012.

Bachelor’s in science (Mathematics Statistics), Acharya Nagarjuna Universit 2007-2010.

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