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SAS Programmer/Biostatistician

St. Louis, Missouri, United States
December 05, 2018

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PRAJITHA NAIR **** Wissant Lane

St. Louis MO


Phone: 314-***-**** E-mail:


I am an enthusiastic passionate professional with expertise in SAS programming and Statistical Analysis and looking for a position in my expertise area to contribute.

I worked as SAS Programmer/Statistician and also responsible as Project Manager of SAS Programming in clinical domain. I am having an extensive experience of 6+ years in analysis, design and development, validation of Clinical Trial projects for CROs/Pharmaceutical companies using SAS software in this field.

Authorize to work in US under any employer without sponsorship. Looking for mainly remote positions or anywhere around St. Louis, MO.

My LinkedIn Profile:


To work hard with firm determination and positive attitude in a capacity where my skills, knowledge and creativity can be put together for productive results

Professional Summary

Started the career as a Research Fellow (1year exp.) at Kerala Forest Research Institute, Thrissur in a project awarded by MoEF, Govt. of India.

6+ years experience as SAS Programmer/Statistician for clinical trials

2+ years of experience as a Project Manager in SAS programming

Certified in BASE SAS programming

Managing the team size of 13-15

Worked for the top CROs/Pharmaceutical companies in Europe (Switzerland, France and Germany) and America

Experience in Phase- I, II, III trials and observational studies in various therapeutic areas

Strong experience of SAS Base, SAS Macros, SAS SQL, SAS Stat, SAS Graph, SAS ODS

Sound knowledge in the following activities:

oAid in the preparation of CRF

oPreparation of CRF manual

oPreparation of Data Management related documents like annotated CRF, DDT, Data Validation Document

oReview clinical data for outliers, invalid and illogical data points

oDevelopment/Review of Statistical Analysis Plan

oPreparation of STL templates

oCreation of SDTM/ADaM/ADS specs as per the requirement

oSound knowledge in SDTM and ADaM

oClosely working with the Statisticians/PK scientist to provide SAS programming skills to analyze clinical trials data and generate tables, listings and graphs

oPervasive knowledge of Statistical Analysis Plans, Standard Operating Procedures and Protocols of clinical trials

oGenerating SAS code for randomization schemes in order to preserve blinding for the study

oGenerating macros and utilities

Good understanding of data management principles, data manipulation and data analysis

Strong quantitative and analytic abilities to analyze and validate data

Excellent knowledge and proficiency in using SAS/ODS to create output files in PDF, RTF and HTML

Preparation of SAS training materials including presentation, documents, objective questions and practical questions

Strengths include excellent interpersonal skills, strategic planning with most favorable utilization of resources and strong object-oriented programming skills

Provide training in SAS programs

Preparation/Review of Standard Operating Procedures (SOP)

Presented project reports and status reports to clients and management

Good management skills and involved in recruitment activities

Presented paper entitled “Applying INVALUE STATEMENT in PROC FORMAT for Ordering Character Variables “in NESUG conference 2011 held at Maine, Portland

As a Project Manager in SAS, roles and responsibilities include:

Preparation of training documents and train new SAS programmers

Plan, organize and manage the team as per the project requirement

Resource allocation

Deliver quality deliverable within the proposed project timelines

Foresee the project risk and mitigate the risk involved

Guiding and mentoring Junior Statistical Programmers and reviewing the programs

Professional Experience Total Exp.: 7 years

Project Manager of SAS Programming cum SAS Programmer/Statistician at Cognub Decision Solutions (Erstwhile KREARA SOLUTIONS PVT LTD), Technopark, Trivandrum from August 16, 2006 till September 14, 2012 (6years).

Research Fellow at Kerala Forest Research Institute, Thrissur from June 2005 to August 2006 (1year).

Educational Qualification

Master of Science (M.Sc Statistics)

Qualification Level




Year of Graduation

M. Sc.


Mahatma Gandhi University, Kerala


B. Sc.


Mahatma Gandhi University, Kerala


Technical Skill


Clinical Trials: Phase I, II, III, and IV

Project Details

Period: August 16, 2006 to September 14, 2012

Few project details are as follows:

Project Manager/Senior SAS Programmer for FTE model

Role: Project Manager/Senior SAS Programmer for Phase-1B/2A/2B studies [(ICON Development Solutions) 2009-2012]


Worked as a contractor for a leading CRO (ICON Development Solutions)

10-15 team members who work on different projects as SAS programmers and QC personnel

Have worked on the projects from top CROs/Pharmaceutical companies like Eisai, Novartis, BMS, Emergent, Takeda, Chimerix, Amgen, Roche, Bayer, Regeneron etc.

My responsibilities include:

oActing as point of contact between client team and Kreara

oWorking as Project Manager for the tasks performed at Kreara

oIdentifying the team, assigning tasks, monitoring and managing the projects

oTask assignment and setting timeline

oLeading teleconferences with client and/or sponsor (as a contractor of ICON)

oUpdating the management on progress of projects

oEnsure that the timeline is met effectively

oAct as a mentor and provide technical solutions to the team

oProviding clarification for the concerns raised for the approaches to be followed in clinical trials

oDeveloping SAS programs for safety and PK/PD for mainly Phase – 1 Studies

oCreation of ADaM/SDTM/ADS spec

oIdentifying data issues logically and statistically and working with DM team to get it resolved

oDevelopment of figures based on the template of client standards

oReview of SAP based on protocol and TFL Templates

oPreparation of TFL templates

oAid in the determination of the number of TFL required and cost-estimation

oPreparation of TFLs using ODS RTF and/or standard automated macro for report

oPerforming QC tasks on ADS and TFLs

oProviding SAS Training to the SAS beginners and basic clinical trial concepts, and approaches to be followed

SAS Programmer for a Phase III study

Therapeutic Area: Respiratory

Role: SAS Programmer

Tool: Windows 2000, SAS/BASE, SAS/STAT, SAS/MACRO

This was a phase IV study. In this study my responsibilities includes

oPreparation of CRF Manual

oAssisting in the development of Data Definition Table and SDTM as per the CDISC standards. Interfaced with the data manager in the review and deployment of the database.

oPreparation of Data validation document

oAid in the preparation of Blind Review Document.

oInterfaced with the study statistician to validate the SAS codes for the blind review.

oPreparing tables and listing for the clinical analysis.

oSAS programming for generating listings and summary tables for the safety analysis

oSAS programming for generating listing and summary tables of ECG, Physical Examination and Medical History.

oDeveloping SAS macros for the data validation reports and use them to identify problems with source data that could affect results and follow through to ensure corrections

oAid to the data manager for any data validation issues pertaining to the datasets.

oGenerating SAS code for the dummy randomization of the study to preserve blinding

Statistical analyst for an Observational Study (Case-Control Study)

Therapeutic Area: Oncology

This was a research project related to observational studies namely Case-Control study which involved various genotype variations. The main aim was to determine the risk association between the cases and controls with respect to the genotype status and variation. My responsibility was to lead a team and involved:

oPrepare the statistical Analysis Plan for the objectives

oAids in the development of SAS codes for generating statistical results as per the template

oPrepare the statistical report

SAS Programmer for a Phase-I trial

The study was to convert (mapping) the given study data structure to the targeted structure of CDISC SDTM. My responsibility regarding this study was to prepare annotated CRF and SDTM. Also, assistance provided for the generation of SAS macros and utilities for the mapping from the study data structure in to the targeted Structure of CDISC SDTM.

Paper Presentations

Presented a paper entitled “Applying INVALUE STATEMENT in PROC FORMAT for Ordering Character Variables” under PROC FORMAT section in NESUG conference 2011 held at Maine, Portland. The paper is published in


Appreciation from the management, clients and team members in all the projects been worked

Awarded Employee of the month and Employee of the year 2011-12 (first time introduced for the assessment year 2011-2012)

Designed SAS training curriculum (Base and Advanced) and initiated the training batches

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