PAVANKUMAR BHAGAT
PK/PD Data Scientist, Project Manager
Frankfurt,Hesse
Summary
Results-oriented PK/PD Data Scientist and Project Manager with a proven track record of implementing best practices in Statistical programming and ensuring seamless data submission to regulatory authorities, with 10+ years in SAS/R programming in the pharmaceutical/CRO industry, seeking an opportunity where I can Design and develop statistical programs and have a huge variety of tasks and great opportunities to learn and engage in a strong scientific community.
Overview
10
10
years of professional experience
6
6
years of post-secondary education
1
1
Certification
3
3
Languages
Work History
PK/PD Data Scientist, Project Programmer
Merck Healthcare KGaA - Pharmaceutical Industry
Darmstadt
09.2019 - Current
- Create/ Validate SAS programs to generate tables, listings, figures, and CDISC
- Standard datasets (SDTM/ADaM)
- Led 3 Oncology projects to handle the FDA/EMEA submission-related activities like CRT Package from the end-to-end process including submission of SDTM,
- ADAM, TLF, DEFINE.PDF, ADRG/SDRG, BIMO Listings and SAS pointer documentation
- Develop biometric solutions to automate and standardize the process in statistical programming/ Quantitative Pharmacology
- As a Project Manager ensuring the quality of deliverables, process improvements, and standardization of SAS programs for the in-house projects, educating FSPs and external team members on CDISC concepts, SME review and approval for newly developed TLF, mapping specifications.
- Participate in Process improvements, provides ideas/suggestions on process
- Act as a subject matter expert for the machine learning datasets for Meta- analysis for various projects in Immune-oncology
- Perform analyses defined in the statistical analysis plan as well as ad-hoc analyses as requested by Biostatisticians/Pharmacometricians.
- Coordinated with stakeholders to define project technical requirements.
- Utilized advanced querying, visualization and analytics tools to analyze and process complex data sets.
Senior Statistical Programmer
Cytel Statistical Software and Services - CRO Industry.
Pune
09.2018 - 06.2019
- Create SAS programs, to create client-specific analysis datasets, Tables, listings, and figures
- Lead two projects in programming for the client for the Development of Safety
- Update Reports (DSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), and brochures (IB) in Oncology
- Implement analyses specified in the protocol or the Statistical Analysis Plan (SAP) while working with the project statistician
- Develop and validate tables, listings, and figures as per the client's specifications by using SAS/GRAPHS, SAS/STAT, PROC/COMPARE,
- PROC/REPORTS, and PROC/TABULATE
- Ability to work on data migration from legacy datasets to standard CDISC
- SDTM, ADAM datasets, or any other client-specific standards
- Extensive experience writing macros to develop concise and reusable code for use across deferent Projects
- Maintain Project documentation and Validation/Quality Control documents and Programs in compliance with Sponsor standards
- Individually contribution to SDTM and ADaM data creation, validation and
- Specification creation for DMC, CSR, DSUR, PSUR publications
Statistical Programmer
Novartis Healthcare Private Limited - Pharmaceutical Industry.
Hyderabad
09.2016 - 08.2018
- Understanding of the study Documents and Data (e.g., Study design and objectives, Endpoints, Sample size, Randomization, Study populations, SDTM,
- ADAM, TLF, Statistical Analysis, and Safety)
- Worked closely with the Biostatistics and Data Management teams on various clinical Trials
- Reviewed CRF annotations and database data specifications
- Worked on the creation of analysis datasets and TLF for DMC, CSR, DSUR, and
- PSUR publications
- Perform analyses defined in the statistical analysis plan as well as ad-hoc analyses as requested
- Worked on FDA Submission studies along with submission activities like CRT package, BIMO listings, and SAS pointers in the Oncology Therapeutic area for a complex study that involved 7 phases and a complex study design
- Acted as a mentor for new joiners and trainee programmers
Programmer II
Chiltern Clinical Research Private Limited - CRO Industry.
Bangalore
02.2013 - 08.2016
- Excellent command in producing reports employing various SAS Procedures like Print, Report, Summary, Freq, Tabulate, Means, SQL, Datasets, Contents, and various data steps
- Create and validate Statistical programs for SDTM and ADAM standard datasets
- Table, listings, and figures
- Experience in End-to-End Legacy Data Conversions into SDTM domains for eCTD Submissions
- Perform validation on derived datasets and follow the standard operating procedures during the validation
- Extensive experience in implementation of various standard models defined by CDISC, with special focus on CDASH and SDTM, annotating, reviewing submission ready SDTM CRFs
- Maintain the proper QC documentation
- Ensure deliverables meet quality standards and project requirements.
Education
Master of Science - Health Data Science, Electronics and Communication
University of Manchester
Manchester, UK 09.2021 - Current
Bachelor of Science - Engineering
Visvesvaraya Technological University
08.2008 - 08.2012
Skills
SAS/Base, SAS/Advanced Macro, STAT, GRAPH, SQL
CDISC(SDTM/ADAM)
Tables/Listings/Figures SAS/MacrosR Markdown, R programming
Definexml , Pinnacle 21 ,
ICH-GCP, GxP
Project management, Team Management
Python/Tableau
Machine Learning
Agile Methodologies
Therapeutic Areas
Oncology
Cardiovascular Systems
Infectious Diseases
Opthalmology
Nervous Systems
Certification
[Base SAS], [Pearson Education]
Accomplishments
- Single-Handedly involved in the submission package for FDA/EMEA regulatory authorities to submit CRT package (SDTM/ADAM/TLF/Reviewer Guides/ Define Documents) and worked on ad hoc requests from regulatory agencies in Oncology
- Trained a deep neural network classifier (CNN) to classify the tissue type in MRI image classification
- Presented a Topic on timing variables in SDTM at the external conference in Statistical programming (CONSPIC) in Chennai India in 2016
Timeline
Master of Science - Health Data Science, Electronics and Communication
University of Manchester
09.2021 - Current
PK/PD Data Scientist, Project Programmer
Merck Healthcare KGaA - Pharmaceutical Industry
09.2019 - Current
Senior Statistical Programmer
Cytel Statistical Software and Services - CRO Industry.
09.2018 - 06.2019
Statistical Programmer
Novartis Healthcare Private Limited - Pharmaceutical Industry.
09.2016 - 08.2018
[Base SAS], [Pearson Education]
05-2014
Programmer II
Chiltern Clinical Research Private Limited - CRO Industry.
02.2013 - 08.2016
Bachelor of Science - Engineering
Visvesvaraya Technological University
08.2008 - 08.2012