SUMMARY

Around *+ years of experience in SAS Programming with good knowledge of advanced statistical methods in Pharmaceutical and Biotech industries.

Experience in creating tables, listings and graphs to generate clinical study reports as per the requirements of the statisticians referring to the Statistical Analysis Plan (SAP).

Experienced in SAS/Base, SAS/Macros, SAS/SQL, SAS/GRAPH, SAS/STAT, and SAS/ODS.

Fluent in SAS Programming techniques (MEANS, FREQ, SUMMARY, TABULATE, REPORT etc) and SAS/STAT procedure (REG, LIFE TEST, CORR etc) for summarization and statistical analysis purposes.

Created SDTM datasets (version 3.2) for LB, AE, DM, VS, EX, TU, TR, RS etc from Raw Data sets by following CRF, Dataset Specifications and CDISC SDTM Implementation Guide.

Developed Analysis Datasets (ADaM) as per CDISC standards, ADaM Implementation Guide, Mock shells and Specification document provided by statisticians.

Knowledge of Pinnacle 21 define.xml file (link of metadata) and SDRG (Study Data Reviewer’s Guide).

Experience in handling PK/PD modeling datasets like Pharmacokinetics Concentrations (PC) and Pharmacokinetics Parameters (PP) along with analysis datasets ADPP, ADPC.

Experience in Integrated Summaries of Efficacy (ISE) and Safety (ISS) according to Statistical Analysis Plan (SAP) and Protocol.

Generate Customized Report Writing using reporting tool like PROC REPORT and Experienced in generating RTF, PDF and HTML formatted files using ODS Facility.

Good working knowledge of FDA regulations and GCP/ICH guidelines as related to clinical programming processes.

Developed numerous Ad Hoc reports as required by Statistician and FDA.

Easily adapt to changing circumstances, policies, work assignments, and/or team members.

TECHNICAL SKILLS

Operating System

Windows 2000/XP/07/08, UNIX.

SAS Tools

SAS/BASE 9.2/9.4 SAS/STAT, SAS/MACRO, SAS/SQL, SAS/GRAPH, SAS/ODS, Enterprise Guide

SAS Procedures

Report, Freq, Means, Summary, SQL, Transpose, Univariate

Databases

Oracle 7.x/8, Oracle Clinical, SQL Server

Languages

SQL, PL/SQL, HTML, CSS, XML

Application Software

MS Office - Excel, Power Point, Access and Word

EDUCATIONAL QUALIFICATIONS

Bachelors of pharmacy – Jawaharlal Nehru university, Anantapur, India

Involved in statistics for Research articles – 1. Knowledge on ATT among 3 government hospitals

2.Gullain Barre syndrome

Masters of Health Informatics – New England College, New Hampshire, USA

PROFESSIONAL EXPERIENCE

Dataceutics June 2018 - Present

Rockville, Maryland

Senior Clinical SAS Programmer

Responsibilities:

Design and specify study data tabulation models and analysis data models for clinical trials or for the integration of clinical trial data from multiple trials (e.g. ISS and ISE datasets). These designs and specifications are completed in accordance with common industry standards and conventions, statistical requirements and specifications, and/or clinical trial sponsor’s requirements.

Generate complete and efficient analysis data models following approved dataset designs or specifications.

Performed independent validation of datasets created by other programmers or statisticians.

Developed SAS programming codes and generate complete and accurate statistical output reports of trial data in well-defined formats.

Developed SAS programming codes to independently validate statistical output reports of trial data generated by other programmers or statisticians.

Developed and test SAS codes for clinical trial database(RAVE, Oracle Clinical, and SAS Database) logical checks and reports for ongoing data review.

Documented data and programming information in accordance with corporate SOPs and (FDA/CFR, ICH/GCP, CDISC).

Archived clinical trial data (study data tabulation models and analysis data models) and programming information in accordance with corporate archival SOPs and guidelines.

Developed and provided expertise in other programming and system administration areas when required.

Provided technical guidance and support to Peer Statistical Programmers.

Contributed to the continuous improvement of the statistical programming processes and procedures.

Contributed to the establishment of therapeutic area programming standards/conventions/procedures within assigned therapeutic areas as a lead programmer.

Contributed to the establishment of client specific programming standards/conventions/procedures for assigned clients when required.

IQVIA March 2013 – May 2018

Durham, NC

Clinical SAS Programmer

Responsibilities:

Experience working on Patient support studies and various market research for post marketed drugs.

Developing programs for safety tables/listing for adverse event cases disposed in IRT and ArisG safety database.

Perform code review, verify if the specifications were followed, document and validate SAS macro library.

Provide analytic support for developing a USDS metrics to understand trends and project status within safety reporting which results in more efficient pharmacovigilance processes.

As a QC programmer, involved in validating the work of fellow programmers using PROC COMPARE and prepare QC report without data issues.

Interact with Biostatisticians, Statistical programmers, MAP Leads, Clinical Safety Associates and Case Management Managers.

Effectively communicate within a multi-disciplinary project team.

Annotating new and legacy CRF (Case Report Form) based on SDTM standards to create and map current/legacy studies for submission activity and study level. Knowledge of CDISC SDTM implementation guidelines required.

Created specifications for data imports from non-eCRF guidelines (external vendors) and have the experience of reconciliation process (missing time points, PT deviation etc.) for external data (Genomics, external file types etc.).

Diagnosing errors, warnings, and programmatic issues or data issues in Open CDISC Reports.

Creating Submission deliverables on SDTM submission package for multiple studies.

Updating and validating Define.xml with the use of OPEN CDISC validator.

Using SAS to write, read, export and import to different data file formats (including spreadsheets, delimited files, and Microsoft Excel / Access tables).

Proficient in ODS RTF, generating ad-hoc tables and listings using SAS/ODS.

Directed SAS output to HTML and PDF files using Output Delivery System facility to write efficacy and safety reports.

Atos

Walpole, MA April 2012– February 2013

Clinical SAS Programmer

Responsibilities:

Validation programmer for bio stats team involved in generating Interim analysis outputs by using CDISC guidelines.

Involved in creation and validation of SDTM datasets for both safety and efficacy further lead to ADaM datasets creation.

Working on Phase II and Phase III studies parallelly in developing vaccines for respiratory viruses in infants.

Working on reviewing ADaM specifications for safety and efficacy studies (vaccines) by checking SAP, protocol and CRFs.

Creating and reviewing ADaM datasets by using ADaM specs according to the TLF shells and SAP.

Involved in creation of tables and listings along with validation of tables.

Doing validation documentation reporting for publishing the interim results.

Participate in team meetings with the safety team, medical writing team and some third-party vendors regarding the data collection and reporting them about significant errors.

AdHoc reporting as required by the medical writing team and the supervisors to update tables or create new tables and do re-runs and refresh the data for submissions.

Performing data reconciliations as needed by the safety team to see if there are any discrepancies in AE data and MAE data. To check if the lab data received from the vendors is accurate with some data check programs.

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