Amee Sangeet
Brampton,CA
Summary
Versatile Senior SAS Programmer with 5+ years of experience in Biotechnological and proficient in Clinical SAS programming.
Effective at supporting team needs with high-quality code, subject matter expertise and collaboration skills. Skilled programmer and complex problem-solver experienced in data analytics and report writing.
Innovative professional with proven track record of developing solutions.
Adept in multiple programming languages and offers great task prioritization and organizational skills.
Proven ability to troubleshoot complex programming problems.
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Senior Clinical SAS programmer
Pharma Medica Research Inc.
09.2022 - 07.2024
- Worked on safety and efficacy TFLs for over 35+ studies with diverse therapeutic areas.
- Assisted in the development of CDISC SDTM and ADaM datasets to support clinical study reports and integrated summaries of safety and efficacy.
- End to end validation for almost all of the studies using Pinnacle 21 Enterprise, including generation and review of CSDRG, ADRG and define.xml v2.1.
- Documented and archived clinical trial data (raw data, SDTM, and ADaM datasets) and accordingly programmed documents as per sponsor’s specific requirements.
- Attained the required analytical representation of the raw data in terms with the Protocol.
- Well verse with ADSL, ADLB, ADEX, ADVS, ADAE, and an extensive number of SDTM domains like DM, AE, VS, LB, EG, MH, QS, FA, PR, SR etc.
- Go through the source documents like Study protocol, SAP, TLG shells, CDISC Adam guidance to get all subject-level efficacy parameters of Clinical Trials.
- Improved internal programming standards by creating reusable macros, code libraries, and templates for consistent code development across projects.
- Collaborated with cross-functional teams to ensure accurate and timely completion of statistical analyses for regulatory submissions.
- Trained new hires on departmental procedures, programming techniques, and best practices for using SAS within a clinical research setting.
- Developed custom SAS programs to support exploratory data analyses, hypothesis testing, and ad-hoc requests from clinical teams.
- Actively participated in project team meetings, providing insight on programming-related topics and ensuring alignment with overall study objectives.
- Conducted thorough quality control checks on all deliverables, ensuring accuracy and adherence to company standards before submission to clients or regulatory agencies.
- Compliant with FDA and PMDA ADaM programming standards to ensure a successful submission.
- Performed data conversion of datasets with two different formats according to CDISC standards, e.g., conversion from Excel data records to SAS datasets and non-CDISC compliant datasets to CDISC compliant datasets.
- Utilized advanced visualization techniques to create clear and informative study results for clinical research presentations and publications.
- Performed thorough code reviews for colleagues, identifying potential errors and areas of improvement to enhance overall team performance.
- Enhanced clinical trial data quality by developing and validating advanced SAS programs for data cleaning and monitoring.
- Provided technical support to team members, resolving complex programming issues and sharing best practices for efficient coding.
- Successfully directed multiple projects simultaneously while maintaining high levels of productivity under tight deadlines.
Clinical SAS Programmer
IQVIA
07.2019 - 09.2022
- Developed efficacy and safety tables including Demographic table, Adverse Events table, Laboratory Shift table and Concomitant Medication tables.
- Involved in writing the specifications for programming SDTM, ADaM datasets for the study and as per the analysis plan.
- Extended knowledge of other statistical analysis due to frequent communications with various departments related to SAS programmer team like CDM and Biostatistics.
- Worked on multiple therapeutic areas, in particular Cardiovascular, Respiratory, Oncology, Endocrinology, Neurology, Infectious diseases etc.
- Validated SDTM and ADaM datasets and created define.xml file and Pinnacle 21 reports.
- Excellent knowledge about 21 CFR part 11 requirements and FDA study requirements.
- Generated output of statistical tables, listings, and graphics/figures (TLG/Fs) according to the Statistical Analysis Plan (SAP) and CDISC formats.
- Prepared SDTM and AdaM Datasets from raw Data files using Import Techniques and modified existing Datasets using Set, Merge, Sort, and Update, Formats, Functions and conditional statements.
- Established and maintained cooperative and effective working relations with fellow colleagues and employees.
- Communicated effectively orally as well as in writing, to scientific and non-scientific groups.
- Kept abreast of industry trends in statistical methodologies, regulatory requirements, and software tools by attending conferences, participating in professional organizations, and completing relevant training courses.
- Developed comprehensive documentation for SAS programs to facilitate knowledge transfer and program maintenance.
- Analyzed, reviewed and revised programs to increase operating efficiency.
Junior SAS programmer
Trulife Pharma Pvt. Ltd.
05.2018 - 12.2018
- Responsible for DM, SV, AE , LB and VS domains
- Lately worked with QS domain as well
- Handled Dropouts and Missing Data by using traditional approach of generating Last-Observation-Carried-Forward (LOCF) data on Visit-wise data
- Developed and tested SAS programming codes for clinical trial database with logical checks and data reports for ongoing data review
- Created SDTM CRF annotation (aCRF) and validated aCRFs generated by others
- Compliant with SOPs, GCP and ICH guidelines
- Developed and validated Tables and listings as per the mock shell
- Interpreted results sections for the clinical study report (CSR)
- Performed the validations of SDTM datasets as per the program requirement and Specifications
- Generated SDTM datasets with respect to all the domains
- Following the tracker sheet completed the assigned tasks in timely manner.
Education
Master of Science - Life Sciences
Ahmedabad University
Ahmedabad,India07.2016
Bachelor of Science - Biochemistry
St. Xavier's College, Gujarat University
Gujarat, India06.2014
Skills
- SDTM
- ADAM
- Advanced SAS programming
- Teamwork and Collaboration
- Pinnacle 21 Enterprise
- SAS BASE, SAS Clinical
- Data Validation Techniques
- CDISC standards expertise
- Adaptive Learning Capacity
- Quality Control Processes
- Database management knowledge
- Statistical Modeling Techniques
Languages
English
Full Professional
Gujarati
Native or Bilingual
Hindi
Native or Bilingual
Certification
- Certified Base Programmer for SAS
- SAS Certified Associate: Programming Fundamentals
Timeline
Senior Clinical SAS programmer
Pharma Medica Research Inc.
09.2022 - 07.2024
Clinical SAS Programmer
IQVIA
07.2019 - 09.2022
Junior SAS programmer
Trulife Pharma Pvt. Ltd.
05.2018 - 12.2018
Master of Science - Life Sciences
Ahmedabad University
Bachelor of Science - Biochemistry
St. Xavier's College, Gujarat University
- Certified Base Programmer for SAS
- SAS Certified Associate: Programming Fundamentals
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