BHASKER CH
Summary
A highly experienced Senior Statistical Programmer with 7+ years of expertise across oncology, immunology, and respiratory clinical trials spanning Phases I–IV. Strong command of ADaM and SDTM development, statistical programming, and therapeutic area focused TFL production. Adept at leading studies, supporting FDA submissions, and collaborating with cross functional teams. Recognized for precision, efficiency, and delivering high quality outputs in fast paced environments.
Overview
7
7
years of professional experience
2008
2008
years of post-secondary education
Work history
Senior Statistical Programmer
WCG Clinical
2023.01 - 2026.02
- Lead programmer for multiple Phase II oncology studies, managing ADaM development, QC, and TFL generation.
- Developed ADaM datasets (ADSL, ADTTE, ADRS, ADEFF, ADLB) aligned with SAP and metadata.
- Produced oncology TFLs and statistical outputs for Breast, Prostate, and Lung cancer studies.
- Created advanced visualizations: KM curves, waterfall plots, swimmer plots, spider plots, forest plots.
- Supported statistical modeling: TTE, ANCOVA, mixed models, logistic and categorical analyses.
- Contributed to FDA submission deliverables including CRT packages, Define.xml review, and P21 validation.
- Performed ISS/ISE integration ensuring consistency in derivations and endpoint definitions.
- Built advanced SAS macros, templates, and automated QC routines.
- Collaborated with statisticians to resolve data issues and ensure endpoint alignment.
- Ensured compliance with CDISC, GCP, MedDRA, and 21 CFR Part 11.
Statistical Programmer
MMS Holdings
2019.01 - 2022.12
- Executed SDTM mapping (IG 3.1.2) for oncology, immunology, and respiratory studies using raw datasets, annotated CRFs, and SAP.
- Developed ADaM datasets with a strong focus on safety domains, including adverse events, exposure, labs, vitals, and concomitant medications.
- Programmed safety TFLs such as AE summaries, AESI analyses, exposure summaries, lab shift tables, vital sign trends, and concomitant medication listings.
- Supported oncology studies by producing tumor assessment listings (TU/TR/RS) and safety-driven outputs for solid tumor indications.
- Contributed to immunology studies by generating safety analyses for immune-related adverse events, lab abnormalities, and treatment-emergent immune responses.
- Delivered respiratory study outputs including safety summaries, exacerbation-related AE analyses, and longitudinal safety trends.
- Performed rigorous QC of SDTM/ADaM datasets and TFLs, ensuring accuracy and consistency across multiple therapeutic areas.
- Utilized SAS procedures (FREQ, MEANS, UNIVARIATE, REPORT, SQL, SUMMARY, TRANSPOSE) to support safety-focused analyses.
- Developed modular SAS macros to automate dataset creation, validation, and safety reporting workflows.
- Collaborated with clinical and data management teams to resolve safety-related data inconsistencies and ensure clean, analysis-ready datasets.
- Mentored junior programmers and participated in cross-functional code and output reviews.
Education
Master of Technology - Electronics & Communication Engineering
Osmania University
IndiaSkills
- Oncology Clinical Programming
- ADaM & SDTM Development
- Time-to-Event (TTE) Analysis
- SAS Macros & Automation
- TFL Programming (Oncology)
- CDISC Standards
- Pinnacle 21 Validation
- ISS/ISE Integration
- FDA Submission Support
- QC & Double Programming
- Statistical Modeling Support
- Beginner R Programming
- SAS: BASE, MACROS, GRAPH, REPORT, SQL, ODS
- ADaM: ADSL, ADTTE, ADRS, ADEFF, ADLB
- SDTM: TU, TR, RS
- Oncology Analysis: TTE, Response Analyses, Tumor Burden Plots
- Tools: Pinnacle 21, SAS Studio, SAS EG
- R: Beginner
- Regulatory: GCP, MedDRA, 21 CFR Part 11
- Exceptional attention to detail
- Strong communication and teamwork
- Quick learner, adaptable to new tools
- Effective in deadline-driven environments
- Analytical and problem-solving mindset
THERAPEUTIC AREA EXPERTISE
- WCG Clinical: Oncology-focused programming across multiple solid tumor indications.
- MMS Holdings: Broader therapeutic exposure including oncology, immunology, and respiratory studies.
Timeline
Senior Statistical Programmer
WCG Clinical
2023.01 - 2026.02
Statistical Programmer
MMS Holdings
2019.01 - 2022.12
Master of Technology - Electronics & Communication Engineering
Osmania University