Statistical programming professional with a track record of delivering robust statistical solutions with experience in data analysis, and programming in accordance with CDISC standards. Known for collaborating effectively within teams and adapting to evolving project requirements, with skills in SAS, and R.
Work History
Principal Statistical Programmer
5 Years 11 Months
ICON, formerly PRA Health Sciences | 08.2020 - Current
Serve as the programming lead for complex studies, programs, or therapeutic areas.
Annotate Case Report Form (CRF), create SDTM specifications and datasets using available raw data as per CDISC standards and create Analysis datasets based of SDTMs following the CDISC standards.
Ensure programming deliverables comply with CDISC standards and regulatory requirements.
Provide technical guidance and mentoring to junior and senior programmers.
Excellent written and oral communication skills.
Perform code reviews and quality checks.
Collaborate with statisticians, data managers, and project managers.
Estimate effort, plan timelines, and manage programming resources.
Experience with submission-ready datasets and global regulatory agencies.
SAS Programmer
6 Years 6 Months
Sure tech Services | 02.2014 - 08.2020
Developing high quality customized tables, reports and listings using Proc Tabulate Proc Summary and Proc Report.
Perform Production and Validation of safety and efficacy tables, listing and graphs.
Collaborated with cross-functional teams to ensure data integrity and compliance with regulatory standards.
Streamlined reporting processes, reducing turnaround time for project deliverables significantly.
Develop statistical and computing reports for Phase I, II and III clinical studies.
Analyzed large datasets to identify trends, providing actionable insights for decision-making processes.
Ensured compliance with regulatory standards by meticulously documenting code changes, program modifications, and version updates.
Developed complex SAS programs for data manipulation and analysis to support clinical trials.
SAS Programmer
4 Months
KFORCE INC. | 09.2013 - 01.2014
Reviewed ACRF and provided actionable feedback to enhance data collection processes.
Involved in Review of mock-shell development, derived dataset specifications, programming specifications, and other process supporting documents.
Contributed to ongoing preparation of SAS datasets for statistical analyses and demonstrations.
Conducted thorough data validation and quality checks to enhance accuracy of analytical results.
SAS Programmer
1 Year 6 Months
WIPRO TECHNOLOGIES | 03.2012 - 09.2013
Developed, maintained and produced statistical programs used in creating analysis datasets, tables, listings, and figures based on provided specifications.
Built programs to create SAS datasets from the clinical database, external data sources, and other sources while following the clinical study’s protocol or statistical plans.
Generated TLGs for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA submission.
Developed programs to create SAS datasets from clinical database and external data sources, adhering to clinical study protocols and statistical plans.
Involved in the process of generating TLG's for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA submission.
Education
Graduate - Information Technology
Bharathidasan University | Tiruchirappally, Tamilnadu, India | 05-2002
Skills
SAS programming
Statistical analysis
Problem-solving
Project management
Attention to detail
Time management
Teamwork and collaboration
Independently working
Timeline
Principal Statistical Programmer
ICON, formerly PRA Health Sciences
08.2020 - CurrentRead More
SAS Programmer
Sure tech Services
02.2014 - 08.2020Read More
SAS Programmer
KFORCE INC.
09.2013 - 01.2014Read More
SAS Programmer
WIPRO TECHNOLOGIES
03.2012 - 09.2013Read More
Bharathidasan University
Graduate from Information Technology
Read More
Protocol Therapeutic Experience
Therapeutic Areas worked: Neurology, Hematology, Vaccine, Oncology.
Non-Protocol Therapeutic Experience
Therapeutic Area: Dermatology.
System Experience
Proficient working in SAS EG, SAS Studio, Workbench.
Expert in application of CDISC standards into creating SDTMs and ADaM datasets.