Prachi Shrirao
Aurora,United States of America
Summary
Statistical programming professional with robust experience in data analysis, programming, and application development. Adept at leveraging statistical software and coding languages to deliver impactful insights. Strong emphasis on team collaboration, reliability, and adaptability to evolving project requirements. Proven skills in data manipulation, algorithm design, and statistical modeling, combined with results-driven mindset.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Principal Statistical Programmer
Fortrea (Formerly Labcorp)
Aurora, Illinois, United States of America
10.2022 - 02.2026
- Perform the role of the Lead Statistical Programmer.
- Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
- Develop and maintain SAS programs to create complete SDTM and ADAM datasets and TFLs, and perform QC of SDTM, ADAMs and TFLs.
- Produce Define XML/PDFs, aCRFs and Reviewers Guides to support SDTMs and ADAMs.
- Develop and/or lead the development of complex specifications for SDTMs and ADAM datasets and contribute to the development of organization and Client standards.
- Review SAPs and TFL shells from a programming perspective for studies and advise on the development of complex TFL shells from a programming perspective.
- Mentor less-experienced programmers in the processes around SDTMs, ADaMs and TFLs.
- Present and share knowledge at department meetings.
- Continually identify and suggest ways to improve the efficiency, quality, and productivity of statistical programming.
- Respond to QA and client audits, and support qualification audits.
- All other duties as needed or assigned.
Sr. Statistical Programmer
Fortrea (Formerly Labcorp)
Aurora, Illinois, United States of America
01.2021 - 09.2022
- Perform the role of the Lead Statistical Programmer
- Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
- Develop and maintain SAS programs to create SDTM and ADAM datasets and TFLs, and perform QC of SDTM, ADAMs and TFLs
- Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs and Reviewers Guides to support SDTMs and ADAMs
- Develop specifications for SDTMs and ADAM datasets.
- Review SAPs and TFL shells from a programming perspective for studies.
- Identify processes within programming that will increase productivity, quality, and efficiency.
- Respond to QA and client audits, and support qualification audits.
- All other duties as needed or assigned.
Sr. Statistical Programmer
Labcorp (formerly Covance)
Mumbai, Maharashtra, India
06.2019 - 09.2020
- Perform the role of the Lead Statistical Programmer
- Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
- Develop and maintain SAS programs to create SDTM and ADAM datasets and TFLs, and perform QC of SDTM, ADAMs and TFLs
- Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs and Reviewers Guides to support SDTMs and ADAMs
- Develop specifications for SDTMs and ADAM datasets.
- Review SAPs and TFL shells from a programming perspective for studies.
- Identify processes within programming that will increase productivity, quality, and efficiency.
- Respond to QA and client audits, and support qualification audits.
- All other duties as needed or assigned.
Sr. Statistical Programmer
Labcorp (formerly Covance)
Aurora, Illinois, United States of America
05.2016 - 03.2019
- Perform the role of the Lead Statistical Programmer
- Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
- Develop and maintain SAS programs to create SDTM and ADAM datasets and TFLs, and perform QC of SDTM, ADAMs and TFLs
- Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs and Reviewers Guides to support SDTMs and ADAMs
- Develop specifications for SDTMs and ADAM datasets.
- Review SAPs and TFL shells from a programming perspective for studies.
Education
Bachelor of Technology and Engineering -
Amravati University
Amravati, Maharashtra, IndiaCertified Clinical SAS Programmer - undefined
Certification - R Programming
Professional Certificate - Data Science and Generative AI
Purdue University
Skills
- Clinical SAS Programming
- R programming language
Affiliations
CDISC Member
Certification
· Certified Clinical SAS Programmer
· Certification in R Programming
· Professional Certificate in Data Science and Generative AI from Perdue University
Language Capabilities
English - ILR 3 (Professional Working Prof)
Marathi – ILR5 (Native or Bilingual)
Hindi – ILR (Full Professional Prof)
Timeline
Principal Statistical Programmer
Fortrea (Formerly Labcorp)
10.2022 - 02.2026
Sr. Statistical Programmer
Fortrea (Formerly Labcorp)
01.2021 - 09.2022
Sr. Statistical Programmer
Labcorp (formerly Covance)
06.2019 - 09.2020
Sr. Statistical Programmer
Labcorp (formerly Covance)
05.2016 - 03.2019
Certified Clinical SAS Programmer - undefined
Certification - R Programming
Professional Certificate - Data Science and Generative AI
Purdue University
Bachelor of Technology and Engineering -
Amravati University
Disclaimer
Employee Signature: ____________________________ Date: _________________________________________
Therapeutic Experience
- Endocrinology: Other Endocrinology – Diabetes Phase IIb
- Hematology: Leukemia – Acute Myelogenous (Phase III)
- Oncology: Gastrointestinal Cancer – Pancreatic (Phase IIb)
- Immunology: Other Immunology - Immunosuppression (Phase IIb)
- Infectious Disease: Viral Infection – Hepatitis (Phase IIb)
- Rheumatology: Arthritis – Arthritis Rheumatoid (Phase I)
Systems Experience
- SAS EG
- Veeva Vault
Other
Not Applicable
Training
Not Applicable