Summary
Overview
Work History
Education
Skills
Personal Information
Timeline
Generic

SHEIK IBRAHIM P S

Technical Lead - SAS Programming
Karur,Tamil Nadu

Summary

Highly organized and self-motivated statistical programmer with 8 years of excellence well specialized in development, and validation of SDTM, ADaM, TLFs and eCRT packages (aCRF, Define.XML, SDRG, ADRG) for FDA standards. Acquired good knowledge on pinnacle validations, documentation work and FDA submission package. Proven track record of managing both the projects and the team to achieve project goals with quality in the planned timeline. I work with all my potential to bring in success through organized skills and teamwork. Always with curiosity to explore and learn more.

Overview

8
8
years of professional experience
4
4
years of post-secondary education

Work History

Technical Lead - SAS Programming

Navitas Life Sciences
03.2025 - Current
  • Reviewed statistical programming activities for oncology studies.
  • Developed and validated the creation of oncology-specific figures (KM, waterfall, and spider plots).
  • Created and reviewed specifications for the development of SDTM and ADaM datasets.
  • Generated and reviewed eCRT packages (annotated CRF, SDRG, ADRG, Define.XML) for submissions.
  • Maintained close communication with the DM and stat team throughout the project for accurate progress and prompt issue resolution.
  • Optimized resource allocation across multiple concurrent projects by closely tracking team capacity levels against project deadlines and milestones.
  • Mentored junior programmers through regular one-on-one meetings, providing guidance on best practices, coding standards, and career growth opportunities.
  • Worked on the analysis of the compassionate use of the drug on real-world data.
  • Developed a dynamic SAS program for patient data listing creation.

Principal SAS Programmer

Navitas Life Sciences
Chennai
10.2023 - 03.2025
  • Developed and validated end-to-end statistical programming activities (SDTM, ADaM, TLFs) for Phase 1, Phase 2, and Phase 3 oncology trials.
  • Validation of SDTM and ADaM datasets by the Pinnacle 21 Enterprise Tool, and close communication with the DM, stat, and programming team to resolve the issue.
  • Proactive communication with the client to develop trust.
  • Worked independently, and provided assistance and guidance to others.
  • Mentored junior programmers and supported their planning, communications, technical issues, and challenging activities.
  • Created delivery packages and eCRT packages.
  • Worked on PK analysis for phase 1 study (SDTM PC, PP datasets, and related ADaM, TLFs).
  • I have taken internal training on oncology-specific datasets (SDTM - TU, TR, RS, and the related ADaM domains).

Senior Statistical Programmer

Parexel
Bangalore
11.2022 - 10.2023
  • Worked on SDTM, ADaM, and TLFs for the unblinded delivery.
  • Acted as the unblinded statistical programming lead and managed/planned the deliverables from the unblinded statistical programming team.
  • Developed and validated SDTM, ADaM, and TLFs for the oncology studies.
  • Experienced in creating Define.XML, aCRF, and Reviewer's Guide (SDRG and ADRG).
  • Validation of SDTM/ADaM datasets using Pinnacle 21 Validator.
  • Created specifications for SDTM and ADaM domains for the programming activities.
  • Experienced in PK outputs creation for the early-phase studies.
  • Trainer for new employees on CDISC standards, internal processes, and SAS programming.
  • Owned department-level initiative for re-creating the structure for biostatistical programming (SDTM, ADaM, and TLFs).
  • Extended programming support to other projects, in addition to assigned pipeline delivery.
  • Experienced in creating Case Report Tabulation (CRT) packages using CDISC standards.

Engagement Lead

Zifo RnD Solutions
Chennai
10.2021 - 11.2022
  • Key point of contact in managing 10+ member FTE team for Europe customer.
  • Played a key role in setting up and stabilizing programming teams in FTE model.
  • Enabled study leads in project planning, status tracking and communicating to the customer.
  • Owned and delivered several studies as Project Manager.

Senior Programmer Analyst

Zifo RnD Solutions
Chennai
05.2020 - 10.2021
  • Owned and delivered several studies as Project Manager.
  • Worked in multiple studies across various phases of clinical trials for FDA and PMDA submissions.
  • Authored Specifications for creating Analysis datasets as per Statistical Analysis Plan(SAP) for safety and efficacy data.
  • Experienced in creating and validating Tables, Listings and Graphs using Base SAS, SAS/Macros, SAS/SQL and SAS/ODS as per SAP and TFL shells.
  • Performed review of Annotated CRF and Reviewer's Guide and SAS programming of production side for SDTM, ADaM and TLGs.
  • Trainer for new employees on CDISC standards, internal processes and SAS programming.
  • Mentored new joiners and provided technical guidance.

Programmer Analyst

Zifo RnD Solutions
Chennai
09.2017 - 05.2020
  • Experienced in development and validation of SDTM, ADaM and TLGs using base SAS, SAS/Macros, SAS/SQL, SAS/ODS for various phases of clinical trials across therapeutic areas.
  • In-depth knowledge in CDISC, FDA and PMDA standards.
  • Worked in legacy studies and recreation of Tables and Listings as per CSR for PMDA submissions.
  • Comprehensive knowledge in standards for annotating CRF and developing Specification and Define.xml for SDTM and ADaM.
  • Specialized in creation of cSDRG, ADRG for FDA submissions.
  • Extensive experience on validation of datasets and outputs through QC programming and Pinnacle 21 validation.
  • Developed macros for automation of SDTM domains like Related Records that are useful across multiple studies.
  • Trained in ICH E3, E6 and E9 guidelines, GCP and GDPR.
  • Trained fellow team members on SDTM/ADaM standards, development of TFLs.
  • Created Reconciliation Reports for SAE and Lab using SAS Output Delivery System (ODS) as a part of Clinical Database Programming.

Education

Bachelor of Technology - BIOTECHNOLOGY

Bannari Amman Institute of Technology
Erode, Tamil Nadu
05.2013 - 03.2017

Skills

Problem solving

Project management

Adaptability

Time management

undefined

Personal Information

Nationality : India

Hobbies : Playing cricket, Bicycle riding.

Timeline

Technical Lead - SAS Programming

Navitas Life Sciences
03.2025 - Current

Principal SAS Programmer

Navitas Life Sciences
10.2023 - 03.2025

Senior Statistical Programmer

Parexel
11.2022 - 10.2023

Engagement Lead

Zifo RnD Solutions
10.2021 - 11.2022

Senior Programmer Analyst

Zifo RnD Solutions
05.2020 - 10.2021

Programmer Analyst

Zifo RnD Solutions
09.2017 - 05.2020

Bachelor of Technology - BIOTECHNOLOGY

Bannari Amman Institute of Technology
05.2013 - 03.2017

Similar Profiles

CREATE PROFILE
SHEIK IBRAHIM P S Technical Lead - SAS Programming