Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
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Manisha Mehta

Senior Statistical Programmer
Hyderabad

Summary

As a Senior Statistical Programmer with 5 years of experience in clinical trial data analysis and programming. Expertise in using SAS to create high-quality datasets and TLFs while ensuring adherence to regulatory standards. Demonstrated success in collaborating with cross-functional teams. Possesses strong organizational, leadership, and communication skills, with keen attention to detail.

Overview

6
6
years of professional experience
6
6
years of post-secondary education

Work History

Senior Statistical Programmer I

Bayer Pharma Pvt. Ltd
Hyderabad
03.2020 - Current
  • Developed and validated demographic and safety tables and listings for CSR submissions.
  • Delivered Post Hoc and ad hoc listings under tight deadlines.
  • Created and validated ADaM and SDTM datasets.
  • Conducted SDTM compliance checks using P21 and QC tools.
  • Leading PSUR/DSUR activity, focusing on resource allocation, time management, quality deliverables, cross-functional collaboration, and process optimization.
  • Worked on PLS requests, in-text tables, and AE.XML outputs efficiently.
  • Possessed a strong understanding of study documentation, including Protocol, SAP, CRF.
  • Mentored new team members, providing guidance and training on best practices and programming techniques to enhance team performance.
  • Supported the team in addressing study and program-related challenges, ensuring timely project completion and high-quality outputs.
  • Collaborated with biostatisticians to provide suggestion from programming perspective.
  • Working experience in SDTM IG 3.2.
  • Worked on Analysis dataset such as ADSL ADAE ADMH ADCM ADVS ADEX.
  • Used SAS procedure like Proc Freq, Proc Mean, Proc Transpose, Proc SQL and other Sas function.

Project SAS Intern

Cytel
Hyderabad
06.2019 - 03.2020
  • Completed training and internship in Clinical SAS.
  • Worked on CRF annotation, protocol review.
  • SDTM dataset and TLF development.
  • Analyzed problems and worked with teams to develop solutions.
  • Developed organizational skills through managing multiple tasks simultaneously while adhering to strict deadlines.

Education

B.E - Electrical, Electronics And Communications Engineering

Nagpur University
NAGPUR
06.2011 - 06.2015

Intermediate - Science Education

CBSE
GIRIDIH
03.2009 - 03.2011

Skills

  • Proficient in SAS (Base, Macro, SQL)

  • Introductory R skills

  • Familiarity with SDTM IG guidelines

  • Basic familiarity with ADaM IG guidelines

  • Effective problem solving

  • Strong analytical skills

  • Project management

Accomplishments

  • Recognized as a top performer with multiple awards and promotions over three years.
  • Key member for training new colleagues for Tool Azure Devops for tracking the progress of a study.
  • Trained new people on company tools and process.
  • Top Performer Award winner for the year 2021, 2022, 2023 & 2024.

Timeline

Senior Statistical Programmer I

Bayer Pharma Pvt. Ltd
03.2020 - Current

Project SAS Intern

Cytel
06.2019 - 03.2020

B.E - Electrical, Electronics And Communications Engineering

Nagpur University
06.2011 - 06.2015

Intermediate - Science Education

CBSE
03.2009 - 03.2011

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Manisha MehtaSenior Statistical Programmer