Summary
Overview
Work History
Education
Skills
Certification
Consent Date
Consent
Affiliations
Accomplishments
Languages
References
Timeline
Generic

Mrityunjay Kumar

Mumbai

Summary

Highly-motivated employee with 17 years of Clinical Statistical Programming experience working in the capacity of Associate Director, desire to take on new challenges. Strong worth ethic, adaptability and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.

Overview

17
17
years of professional experience
1
1
Certification

Work History

Associate Director – Biostatistics & Statistical Programming

Efficacy LfeScience Analytics
Mumbai
12.2021 - Current
  • Supported leadership team in Set-up of Statistical programming team of 65 + individuals for new FSP account
  • Actively involved in recruitment of suitable and skilled employees
  • Actively Collaborated with Leadership, HR, and ADMIN team
  • Conducted intercity recruitment drives at frequent intervals
  • Helped in smooth and speedy onboarding
  • Started knowledge sharing sessions, technical trainings and other team building activities
  • Guided on PHUSE & PharmaSUG paper writing skills which motivated team
  • Stabilized projects and built trust of customer on us
  • Monitored and Maintained attrition rate less than 5 %.

Programming Lead

IQVIA
Mumbai
08.2019 - 12.2021
  • SDTMs, ADaMs, Pinnacle 21 Report, SDRG/ADRG, Patient Profiles, BARDA, CRMD listing, SAP/CRF review and approval, Team management and support, Project Management
  • Actively participating in CST meeting and represent entire Statistical Programming team as POC and provide suggestion
  • Regular meetings with Data Management, Safety, Statisticians for raising queries and issues resolution and discussing timeline
  • Protocol review, CRF review/approval, SAP review/approval, TFL mock-shells review/approval
  • Maintaining Project Tracker to display ongoing, upcoming, completed activities and resources engaged
  • Building MDDT specification for SDTMs and ADaMs, CT table, lookup table as per CDISC and client's standards
  • Creating define.xml, validating SDTMs by Pinnacle 21 report and CSDRG/ADRG review
  • Doing complex programming for any new activities or help team by guiding them with complex derivation logic
  • Taking care of all document’s timely submission in eTMF
  • Worked on rare project tasks CSM (Centralized Statistical Monitoring), QTL (Quality Tolerance Limit), Patient Profiles and published signal reports
  • Worked as Adjudicator to reconcile the reported events with Dose Modification related to thrombocytopenia
  • Hands on and strong knowledge of Data blinding, statistical techniques such as Chisq, Exact, CMH, t-test, ANOVA, ANCOVA, REGRESSION, SURVIVAL ANALYSIS etc.

Team Manager

Cognizant Technology Solution
Mumbai
11.2015 - 08.2019
  • Medical device domains raw data from RAVE database converted to CSISC SDTMs/ADaMs standard, Implemented R statistical programming in place of SAS for the study as per client requirement for one of study
  • Visited client site to Netherlands for 4 months between March 2016 and June 2016 to understand and prepare a plan for standardization of data, built a team of 4-5 people within a year and supported in submission work globally like ad hoc, publication, ISS/ISE etc.

Assistant Manager (Level D)

Accenture
Mumbai
12.2012 - 11.2015
  • This was a Phase 3 study for CNS – Epilepsy trial where intent was to identify how many patients had better life or recovery in QoL when treatment was administered as compared to those who received Placebo
  • This was a single blind, parallel design and multicentric trials
  • Scope included SDTMs, ADaMs, TFLs and submission package for PMDA (Japan) approval as well as ad hoc reports
  • (Client - UCB Pharma, Belgium)

Statistical Programmer II

InVentiv Health
Gurugram
03.2011 - 12.2012
  • (GlaxoSmithKline Consumer Health) Independently handled all studies
  • To extract clinical data from Oracle Clinical (OC) database on periodical basis
  • To create derived datasets, analysis variables, Tables, Listings and Figures for the study
  • To mentor new associates to understand the process better and help in programming tasks
  • Frequent interaction with Study Statisticians and Team Lead
  • Individual contributor and completed 15 Healthcare Projects.

Statistical Programmer

Tata Consultancy Services (TCS)
Noida
03.2010 - 03.2011
  • (Pfizer) Developed macros utilities to create intermediate datasets from raw OC data and then use the intermediate datasets as source to create final analysis datasets for standard safety domains
  • To derive analysis variables, generate Lean datasets from Wide datasets after transposing, imputation of dates and time etc., compare newly created datasets using PROC COMPARE to validate results
  • Software Development Life Cycle (SDLC) Knowledge of SDLC process and Preparing Test Plan for the Code developed
  • Generate TLFs from Analysis datasets, documentation as per programming SOPs.

Statistical Programmer I

CliniRx Research
Gurugram
02.2009 - 02.2010
  • (Newron Pharmaceuticals) Data extraction from OC and data cleaning
  • Creating listings for cleaned subjects for medical review
  • TLFs created for Phase I, II and III studies
  • Safety Analysis datasets created.

Statistical Programmer I

Avesthagen Limited
Bengaluru
02.2009 - 02.2010
  • Data retrieval from OC, QC of CRF data, Created reports for Listings and safety Tables only
  • Documentation and archival as per SOPs
  • Worked on Genome Project to identify genes for longevity and build a curated database.

Research Assistant

Institute of Bioinformatics (IOB)
Bengaluru
06.2007 - 11.2007
  • Human Protein Reference Database, HPRD (NIH, U.S.A), Human Proteinemia, Pancreatic Cancer Biomarker Database, Microarray Data Analysis using R.

Education

Future Leadership Program - Organizational Leadership

National University Singapore
Singapore
09-2022

Master of Science (M.Sc. in Bioinformatics) -

Sri Ramchandra University
01.2022

Bachelor of Science (B.Sc. Biology) -

Vinoba Bhave University
01.2006

Skills

  • Clinical SAS Programming: 17 years
  • CDSIC Experience (SDTM and ADaM programming)
  • CRF review/approval, SAP review/approval, TFL mock-shells review/approval
  • Building MDDT specification for SDTMs and ADaMs, Controlled Terminology (CT) table, Lookup Table as per CDISC and client's standards
  • Creating definexml, validating SDTMs by Pinnacle 21 report and CSDRG/ADRG review
  • Providing study specific trainings to study team programmers to ease their tasks by making sure quality outputs are produced at first time itself which saves additional efforts in future
  • Directly involved in complex programming for any new activities or help team by guiding them with complex derivation logic such as Trial Design Domains, Subject Element, Time to event analysis dataset, creating scrambled data
  • Created data structure for custom ADaM based on bleeding events to be used for efficacy analysis using Anderson Gill model approach
  • Taking care of all document’s timely submission and approval in eTMF to maintain compliance metrics of 100 %
  • Worked on CSM (Centralized Statistical Monitoring), QTL (Quality Tolerance Limit), Patient Profiles, BARDA and published signal reports
  • Hands on experience of statistical techniques such as Chisq, Exact, CMH, t-test, ANOVA, ANCOVA, REGRESSION, SURVIVAL ANALYSIS etc
  • Staff Hiring
  • Staff Coordination
  • Hiring And Training
  • Workforce Improvements
  • Onboarding And Training
  • Technical Proficiency
  • Problem-Solving Skills
  • Programming Languages
  • Presentations
  • Data Analysis

Certification

  • PGDCM (SAS) - ICRI, Bangalore (2006)
  • S*Star Bioinformatics - NUS, Singapore (2005)
  • Base SAS - SAS Institute, USA (2010)
  • Advance SAS - SAS Institute, USA (2013)

Consent Date

07/13/2023

Consent

True

Affiliations

Seasoned presenter at Global PHUSE and PharmaSUG conferences. Presented and published 6 papers till date.

Accomplishments

Innovator award within the company in year 2023.

Languages

Hindi
First Language
English
Proficient (C2)
C2

References

References available upon request.

Timeline

Associate Director – Biostatistics & Statistical Programming

Efficacy LfeScience Analytics
12.2021 - Current

Programming Lead

IQVIA
08.2019 - 12.2021

Team Manager

Cognizant Technology Solution
11.2015 - 08.2019

Assistant Manager (Level D)

Accenture
12.2012 - 11.2015

Statistical Programmer II

InVentiv Health
03.2011 - 12.2012

Statistical Programmer

Tata Consultancy Services (TCS)
03.2010 - 03.2011

Statistical Programmer I

CliniRx Research
02.2009 - 02.2010

Statistical Programmer I

Avesthagen Limited
02.2009 - 02.2010

Research Assistant

Institute of Bioinformatics (IOB)
06.2007 - 11.2007

Future Leadership Program - Organizational Leadership

National University Singapore

Master of Science (M.Sc. in Bioinformatics) -

Sri Ramchandra University

Bachelor of Science (B.Sc. Biology) -

Vinoba Bhave University

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Mrityunjay Kumar