ASHUTOSH KUMAR
Statistical Programmer
Hyderabad,Telangana
Summary
As a Statistical Programmer , I will leverage my advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials, with a focus on any of the following studies; Immunology, Oncology, Cardiovascular, Infectious Disease, Early Development, or Medical Affairs.
Overview
2
2
Languages
4
4
years of post-secondary education
10
10
years of professional experience
Work History
Senior Statistical Programmer II
Bayer Pharmaceutical Pvt. Ltd.
Hyderabad, Telangana
12.2018 - Current
- Working on various Submission activity or interim analysis as per requirement and generating Reports (TFLs) for CSR as per statistician and CTT requirements.
- Leading the team of 4-6 members.
- Lead statistical programming activities as project lead for phase I to IV clinical studies or assigned project-level activities.
- Co-ordinate activities of all programmers either internally or externally assigned to the study/project work.
- Provide input into statistical programming solutions and/or ensure their efficient implementation.
- In consultation with the Statistician, responsible for development of programming specifications of analysis datasets and pooled datasets.
- Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications.
- Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.
- CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings.
Statistical Programmer I
Novartis Healthcare Pvt. Ltd.
Hyderabad, Telangana
05.2017 - 12.2018
- Responsible for programming (according to specifications) analysis datasets, pooled datasets, listings, tables, and figures for studies and for Summary of Clinical Safety (SCS) and Summary of Clinical Efficacy (SCE) with high quality and within milestones.
- Responsible for the integrity of the programming/computing solutions for multiple clinical trials (or equivalent) and/or publication activities.
- Responsible for the full execution of final production output generation (tables, listings and graphics) for projects as the Trial Programmer, ensure high quality for all deliverables, and follow the processes. May lead programming activities for a relatively small project or an indication with guidance from Subject Matter Experts (SMEs)
- Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications.
- Ensure that study documents and specifications are consistent and comply with company standards by providing input into eCRF and data structures, tables, listings and figures for studies and submission activities.
SAS Developer, Lead Programmer
TCS
New Delhi, Delhi
12.2011 - 05.2017
- In conjunction with the statistician, responsible for development of programming specifications of analysis datasets and pooled datasets, study-level programming standards and ensure compliance with project-level/company standards. With guidance, may provide support to development of project-level programming standards, following internal guidelines.
- Review planning of edit checks; assist non-standard, complex data validation programming as needed according to agreed plans for the assigned study/project.
- Provide programming expertise in developing/selecting/modifying basic/intermediate MACROs for reporting standards.
- Maintain up-to-date knowledge of programming software (e.g. SAS/R/S-plus) and guide junior programmers as and when needed.
- Assume the role of subject matter expert / domain expert to ensure seamless outsourcing, according to the agreed contract and internal business guidance.
Education
Bachelor of Engineering - Electrical, Electronics And Communications Engineering
Rungta College of Engineering And Technology
Bhilai 04.2007 - 06.2011
Skills
Statistical analysis
Accomplishments
- Awarded above and beyond for FDA submission of 21 studies in SDTM standard within 6 months.
- Appreciation for for delivering 25 defect free pkpd outputs within 1 month of time span.
- Awarded for an outstanding contribution to the organization for delivering complex studies in short span of time with high accuracy.
- Helped Management to build Statistical programming team of 14 members by providing assistance in interviewing and training them.
Timeline
Senior Statistical Programmer II
Bayer Pharmaceutical Pvt. Ltd.
12.2018 - Current
Statistical Programmer I
Novartis Healthcare Pvt. Ltd.
05.2017 - 12.2018
SAS Developer, Lead Programmer
TCS
12.2011 - 05.2017
Bachelor of Engineering - Electrical, Electronics And Communications Engineering
Rungta College of Engineering And Technology
04.2007 - 06.2011
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