PRAJITHA NAIR

Professional Summary

*+ 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

Managed 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, PROC TEMPLATE

Experience of using different statistical procedures like PROC FREQ to calculate odds ratio and other test statistic, PROC LOGISTIC, PROC REG, PROC GLM, PROC ANOVA, PROC MIXED, PROC LIFEREG, PROC BOXPLOT, PORC UNIVARIATE etc based on the data and SAP requirement.

Engaged in the following activities:

o Aid in the preparation of CRF

o Prepare of CRF manual

o Prepare Data Management related documents like annotated CRF, DDT, Data Validation Document

o Review clinical data for outliers, invalid and illogical data points o Develop/Review Statistical Analysis Plan

o Prepare STL templates

o Create SDTM/ADaM/ADS specs as per the requirement o Closely work with the Statisticians/PK scientist to provide SAS programming skills to analyze clinical trials data and generate tables, listings and graphs from ADaM/ADS

o Assist creating Statistical Analysis Plans, Standard Operating Procedures and Protocols of clinical trials

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

o Generate macros and utility programs

Implemented data management principles, data manipulation and data analysis

Used quantitative and analytic abilities to analyze and validate data

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

Prepared SAS training materials including presentation, documents, objective questions and practical questions

Utilized excellent interpersonal skills, engaged in strategic planning with most favorable utilization of resources

Provided training in SAS to juniors

Prepared/Reviewed Standard Operating Procedures (SOP)

Presented project reports and status reports to clients and management

Exhibited 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 Educational Qualification

MS (Statistics)

Mahatma Gandhi University, Kerala

PRAJITHA NAIR

Technical Skill

SAS Tools: SAS/ BASE, SAS/MACROS, SAS/SQL, SAS/GRAPH, SAS/STAT, SAS/ODS Professional Experience

Vsoft Infoware, Princeton, NJ October 2015 – Present Biostat Programmer

Creating SAP for a Vaccine study

Creating table Shells for same Vaccine Study

Udison Infoware, Bangalore, India Sep 2012-July 2015 Senior SAS Programmer

Created tables on association of Genotypes and Objective tumor response by treatment arms by performing Kaplan-Meier analysis using Proc LIFETEST and Proc PHREG.

Created Safety reporting templates across AE, CM, MH, LB, VS, DS, EX and DM domains

Generated and QCed ADaMs - ADSL, ADAE, ADCM, ADLB, ADVS, ADEX, ADEG, ADDS, ADSF, ADMH

Generated Kaplan-Meier survival plot using Proc LIFETEST and Proc GPLOT.

Produced Statistical Analysis Result for Dose-Corrected Pharmacokinetic Parameters Using Proc MIXED output data

Generated tables on results of Correlative Analyses of Selected Dose-Corrected PK Parameters using Proc REG

Created reports on results of Categorical Analyses of Selected Dose-Corrected PK Parameters using Proc NPAR1WAY and Proc UNIVARIATE

Generated Figures for Pre-dose Conc vs Median, Mean +/- SD, and comparison of OS/TTP/PFS and Created Box plot of PK parameters

Validated SDTM domains using open CDISC

Reviewed Open CDISC output with quality team to complete the relevant documentation on each open issues

Interacted with Open CDISC enterprise team to improve the quality of SDTM data

Created process for Normalizing EDC raw data which will be used by all the downstream programming group

Created standard normalization data for EDC Data

Converted all standard sas macros and sas listings to work in unix environment

Used Opencdisc tool for validating the SDTM for many studies.

Created various metric reports using EDC data which will be presented in management meetings

Created query aging, metric reports to data managers

Wrote SAE reconciliation program

Wrote standard Lab normal range reconciliation program for all studies

Wrote standard central lab reconciliation program for all studies

Implemented macros for Normal range violation reports(Graphs showing high and low ranges)

KREARA Solutions, Trivandrum, India Aug 2006 – Sep 2012 Project Manager/Senior SAS Programmer for FTE model for Phase-1B/2A/2B studies

[client: (ICON Development Solutions) 2009-2012]

PRAJITHA NAIR

Tool: SAS/BASE, SAS/STAT, SAS/GRAPH

Managed as a contractor for a leading CRO (ICON Development Solutions) with 10- 15 team members who worked on different projects as SAS programmers and QC personnel

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

Prepared training documents and train new SAS programmers

Planned, organized and managed the team as per the project requirement

Allocated Resources

Delivered quality deliverable within the proposed project timelines

Foresaw the project risk and mitigate the risk involved

Guided and mentored Junior Statistical Programmers and reviewing the programs o Acted as point of contact between client team and Kreara o Identified the team, assigning tasks, monitoring and managing the projects o Assigned tasks and set timelines

o Led teleconferences with client and/or sponsor (as a contractor of ICON) o Updated the management on progress of projects

o Ensured that the timeline is met effectively

o Acted as a mentor and provide technical solutions to the team o Provided clarification for the concerns raised for the approaches to be followed in clinical trials

o Created ADaM/SDTM/ADS spec

o Developed SAS programs for SDTM, ADaM/ADS datasets including safety and PK/PD.

o Developed SAS programs for safety and PK/PD TFLs from ADaM/ADS datasets for mainly Phase – 1 and II Studies

o Identified data issues logically and statistically and worked with DM team to get it resolved

o Worked closely with statistician on TFL template issues and SAP o Developed figures based on the template of client standards o Reviewed SAP based on protocol and TFL Templates o Prepared TFL templates

o Aided in the determination of the number of TFL required and cost-estimation o Prepared TFLs using ODS RTF and/or standard automated macro for report o Performed QC tasks on SDTM, ADS, ADaM datasets and TFLs o Provided 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 o Prepared CRF Manual

o Assisted in the development of Data Definition Table and SDTM as per the CDISC standards.

o Interfaced with the data manager in the review and deployment of the database. o Prepared Data validation document

o Aided in the preparation of Blind Review Document. PRAJITHA NAIR

o Interfaced with the study statistician to validate the SAS codes for the blind review. o Prepared tables and listing for the clinical analysis. o Created SAS programs for generating listings and summary tables for the safety analysis

o Created SAS programs for generating listing and summary tables of ECG, Physical Examination and Medical History.

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

o Assisted data manager for any data validation issues pertaining to the datasets. o Generated 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: o Prepared the statistical Analysis Plan for the objectives o Aided in the development of SAS codes for generating statistical results as per the template

o Prepared 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.

Prepared annotated CRF and SDTM

Assisted in 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 http://www.nesug.org/Proceedings/nesug11/pf/pf05.pdf. Achievements

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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