Sas Programmer Clinical Trial

Name: Sritheja

Phone: 612-***-**** Email: ****.*****@*****.***

SUMMARY:

Certified SAS programmer and have experience within the pharmaceutical/biotech industry or CRO.

SAS programming experience in generating Analysis Datasets/SDTM/ADaM

Experience in producing and validating Tables, Listings and Graphs TLG's using Base SAS, SAS/Graph, SAS/Macros and SAS/ODS according to Statistical Analysis Plan SAP.

Broad Knowledge of Life Sciences and drug development process from protocol through FDA submissions in the clinical trial process Phase I IV

Extensive Knowledge of both CDISC SDTM and ADaM models.

Responsible for creating ADaM safety datasets such as ADSL, ADLB, ADVS, ADEX, ADPC (concentration), ADPP (parameter), and POPPK (NONMEM) datasets, PK non-compartmental (NCA) tables, figures, and listings (TFLs).

Experience in both Clinical SAS programmer and Statistical programmer

Knowledge of creating Case Report Tabulation CRT's using CDISC standards

Experience in Phase I - IV clinical trials and FDA submissions

Experience in Producing RTF, HTML and PDF formatted files using SAS/ODS.

Knowledge in creating tables and listings programming for ISS Integrated Summary of Safety and ISE Integrated Summary of Efficacy to the FDA.

Experience in SAS/BASE, SAS/SQL, SAS/MACROS, SAS/GRAPH, SAS/STAT, and SAS /ODS in Windows and UNIX environments.

Knowledge of MedDRA, WHO-DRUG, CTC Common Toxicity Criteria, FDA regulations 21 CFR part 11, ICH guidelines and GCP requirements in new drug development and application process

Experience on generating Validation Engine, Compliance Check, Define.xml Generation, Regulatory Submissions Support, Traceability and Audit Trail outputs for FDA regulatory submissions.

Having Knowledge on Preparing Datasets, Running Validation, Reviewing the Validation Report, Fix Errors and Revalidate, Generate Define.xml in P21.

Working experience in Data cleaning and edit checks.

Worked with different clinical trial domains like Demographic, Adverse Events AE, Serious Adverse Events SAE, Disposition, Medical History MH, ECG, Exposure Ex, Concomitant medication CM, Vital Signs VS and Laboratory Data lab data . Etc.

Proficient in extracting data from Oracle Database into SAS data files using SQL Pass-through facility.

Worked in various therapeutic areas like Oncology, Vaccines, Gastroenterology Etc.

Experience in generation of Tables, Listings (TLF’s) by following Statistical Analysis Plan (SAP), Mock shells, and Programming plan.

Experience in independent and manual validation of TLF’s by thoroughly following study specification documents.

TECHNICAL SKILLS:

SAS: Base/SAS, SAS/MACRO, SAS/ODS, SAS/GRAPH, SAS/STAT, SAS/SQL

Databases: Oracle, SQL Server 2000, MS Access

Languages: C, SQL, PL/SQL, HTML, Visual Basic 6.0

Operating Systems: Windows 95/98/NT2000/XP, UNIX

PROFFESIONAL EXPERIENCE:

ACCENTURE SOLUTIONS Pvt.Ltd Hyderabad, India

Role: Medical Service Associate May 2021 – Feb 2022

Develop standard SAS program modules for specific Statistical computing. Develop program to retrieve and analyze data from available databases and place data into SAS or other types of data files. Provide analysis datasets using programs which carry data forward, determine protocol violations and valid data points, restructure datasets. Coordinate the organization and storage of all programs, datasets, and output for drug projects.

Responsibilities:

•Review approved Protocol and Study setup documents.

•Develop SAS programs/run standard macros for generating SDTM Datasets, Tables, Listings, and Trial Specific Outputs.

•Exact data from available databases and place data into SAS or other types of data files

•Create and review Submission Documents, Specifications for safety/standard outputs.

•Adhere to all client and Accenture SOPs as applicable.

•Enhance technical skills relevant to statistics and programming.

•Mentor new hires associates in their new roles, assist with questions, and provide guidance for successful Delivery.

•To carry out other responsibilities as and when assigned by the India Service Delivery Lead/Statistical Programmer Manager.

Created SAS datasets using CDISC Study Data Tabulation Model SDTM /ADaM Implementation guide for Statistical summaries and Analysis.

•Created tables and listings according to the guidelines and specification of the client.

•Validation of analysis data sets summary tables and data listings as per the team specific QC procedures.

•Developed independent QC programs for validating the datasets and compared the values using PROC COMPARE

•Involved in validation Patient profile vs. listings.

•Programming planning and co-coordinating, programming testing and documentation of statistical programs for use in creating statistical tables and listing summaries, programming of database quality control checks, debugged macros, and other programs to ensure cleanliness of log.

•Developing and planning programming documentation including plans and specifications as appropriate.

•Performing and planning the development implementation and validation of new process technologies macros and applications coordinating with the lead statistician and the lead programmer.

•Providing advanced technical expertise in conjunction with internal and external clients and independently brings project solutions to SP teams and the Statistical Programming department and participates in clinical project team meetings as required.

•Develops standard SAS program modules for specific statistical computing.

•Develop programs to retrieve and analyze data from available databases and place data into SAS or other types of data files.

•Provide analysis datasets using programs which carry data forward, determine protocol violators and valid data points, restructure datasets, etc.

CYTEL STATISTICSL SERVICES Hyderabad, India

Role: Statistical Programmer Nov 2017 – May 2020

Description: Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty years, Cytel's scientific rigor and operational excellence have helped biotech and pharmaceutical companies navigate uncertainty, prove value, and unlock the full potential of their data.

Responsibilities:

•Create analysis data sets, tables, and listings for High Priority requests.

•Perform Safety for Interim analysis and Final analysis.

•Worked with all kinds of Clinical Trials data such as Demographic data, Adverse Events, AE Serious Adverse Events, Lab data and Vital Signs.

•Developed SAS macros to create tables and listings for Clinical Study Reports and regulatory submissions.

Writing new specifications and verifying already written specifications for the Analysis datasets

•Created SAS datasets using CDISC Study Data Tabulation Model SDTM /ADaM Implementation guide for Statistical summaries and Analysis.

•Experience on CRF annotation, SDTM mapping and specifications creation, SDTM data set creation and validation, ADaM mapping and specification creation, ADaM data set creation and validation.

•Importing the data and Exporting the Data via SAS Data steps using IMPORT and EXPORT Procedures

•Data manipulation using various Statements and SAS/FUNCTIONS

•Run SAS functions like SCAN, SUBSTR, COMBL, TRIM, INTCK, INTNX, MEAN, RANGE, CEIL, FLOOR, ROUND, ABS, SUM, DATE and TIME etc.

•SAS/ODS procedures generate graphs and Customized reports using Output Delivery System (ODS)

•Creating new data files using import techniques and modified existing data sets using SET, SORT, MERGE, and conditional statements

•Combining using Appending, Concatenating and Interleaving of SAS datasets

•SAS generating report procedures like PROC PRINT, PROC REPORT, PROC FREQ, PROC MEANS and PROC TRANSPOSE.

SIRO CLINPHARMA Hyderabad, India

Role: SAS Programmer Jun 2015-Aug 2017

Involved in Data Cleaning and Edit checks

Worked on creating Analysis Datasets

Generated Tables, Listings and Figures TLF's

Created ad hoc programs to provide information to the project team and/or client, as required.

Involved in Validation of Tables and Listings for clinical study reports.

Developed and modified different standard safety reports after study initialization and data extractions.

EDUCATIONAL QUALIFICATIONS:

Osmania University, Hyderabad, India

Bachelors in Pharmacy, August 2012 – May 2016

CERTIFICATION:

Base & Advanced SAS Programmer

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