Suhasini Patil
Mountain House,CA
Summary
Accomplished Certified Base SAS Programmer experienced in leading statistical programming initiatives for Phase I–IV global clinical trials. Achieved regulatory-compliant SDTM, ADaM, and TLFs through expertise in Base SAS, SQL, and statistical modeling while collaborating effectively with biostatistics, data management, and clinical teams. Focused on delivering innovative programming solutions that drive clinical development success and adhere to industry best practices.
Overview
1
1
Certification
23
23
years of professional experience
Work History
Sr. Statistical Programmer II
AstraZeneca Pharmaceuticals
09.2020 - Current
- Project Programming lead for Oncology studies.
- Oversaw external vendors to maintain quality, compliance, and adherence to project timelines.
- Perform in-house programming activities for ISS, DSURs, IBs, BIMO, SRC, IDMC, CSR, ad hoc requests, OSI- BIMO reports and CRT package transfer.
- Collaborated with cross-functional teams to enhance accuracy and consistency of statistical outputs across projects.
- Validated and documented statistical programs to meet regulatory guidelines and support audit readiness.
- Working on Solid and Heme clinical trial for early and late phase trials.
- Currently leading establised compound. Supported sucessfull FDA submisson work. regualtory work.
- Led SAS programming for clinical trial datasets supporting regulatory submissions and statistical analysis.
- Developed SDTM and ADaM datasets aligned with CDISC standards and protocol requirements.
- Programmed tables, listings, and figures for study reports and submission packages.
- Performed quality control reviews for datasets, outputs, and programming specifications.
- Collaborated with biostatisticians, data managers, and clinical teams to resolve data issues.
- Created and maintained documentation for analysis datasets, specifications, and programming deliverables.
- Optimized programming workflows to improve consistency, traceability, and delivery timelines.
- Mentored programmers on SAS conventions, validation practices, and submission standards.
- Managed multiple concurrent projects effectively by prioritizing tasks based on criticality, resource availability, and target dates.
- Collaborated with cross-functional teams to design effective statistical analysis plans, aligning project goals and timelines for successful execution.
- Provided expert consultation on statistical methodology for various projects, enhancing overall study designs and analytical approaches.
- Adapted quickly to new software tools and technologies, maintaining an up-to-date skillset relevant to the evolving needs of statistical programming in clinical research.
- Fostered a positive work environment by promoting collaboration, open communication, and continuous learning among team members.
- Trained new hires on company-specific programming languages and practices, accelerating their integration into ongoing projects.
- Served as a mentor for junior team members, providing guidance and support in the development of their programming skills and career growth.
- Conducted thorough peer reviews of colleagues'' work to ensure accuracy, consistency, and adherence to established standards.
Sr. Statistical Programmer Consultant
Ideal Consultant LLC.
02.2020 - 03.2020
- Provided consulting services for Myovant Sciences in California, USA.
- Developed SAS programs for SDTM and ADaM datasets supporting clinical study deliverables.
- Validated tables, listings, and figures for accuracy against statistical analysis plans and specifications.
- Prepared programming specifications for datasets, outputs, and analysis-ready deliverables.
Principal Stat Programmer
inVentiv Health
03.2016 - 02.2017
- Collaborated with Boehringer Ingelheim in Germany.
- Coordinated and managed statistical programming activities, ensuring alignment with project timelines and regulatory standards.
- Led programming efforts, monitored project progress, and provided technical support and guidance to junior statistical programmers, fostering skill development.
- Developed utility SAS macros to streamline programming processes and enhance efficiency in project execution.
- Worked on projects in the area of Asthma, Pain, Cardiovascular, and Myelodysplastic syndromes (Oncology).
Statistical Programmer - Asst. Manager
Accenture Service Pvt Ltd.
08.2010 - 03.2016
- Collaborated with client UCB, USA, to deliver project requirements.
- Developed SAS programs for dataset generation, validation, exploratory analysis, and ISS, enhancing data accuracy.
- Involved in successfully setting up and managing the SDTM CRF Annotation Project team.
- Set up and managed the SDTM CRF Annotation Project team.
- Educated and supported new associates in understanding SDTM and ADaM standards.
- Worked on multiple projects in the area of Epilepsy, Rheumatoid Arthritis Crohn’s disease (CD), Parkinson’s disease, Restless legs syndrome (RLS).
Sr Statistical Programmer
PharmaNet Clinical Services
06.2007 - 08.2010
- Engaged with multiple clients to understand their needs.
- Generated derived datasets and summary reports (TLF/TLG) using SAS to support data analysis and decision-making.
- Conducted CDISC mapping and produced SAS datasets using SDTM and ADaM models to ensure compliance with regulatory standards.
- Contributed to projects in Vaccine, Dermatology, Diabetes, and Malignant Tumors, enhancing data quality and insights for clinical studies.
Associate Clinical Programmer
Pfizer Pharmaceutical Pvt Ltd
12.2006 - 05.2007
- Led SAS programming for clinical trial datasets, tables, listings, and figures supporting regulatory submissions.
- Developed SDTM and ADaM specifications aligned with CDISC standards and protocol requirements.
- Reviewed program output and performed quality control to ensure statistical accuracy and submission readiness.
- Collaborated with biostatisticians, data management, and clinical teams to resolve data issues promptly.
Statistical Analyst
Novartis Healthcare Pvt. Ltd.
06.2006 - 12.2006
Executive –Biometrics
Reliance Clinical Research Services Pvt. Ltd.
01.2004 - 05.2006
Education
Master of Science (MSc) - Statistics
Mumbai University
Mumbai, India01-2003
Bachelor of Science (BSc) - Statistics
Mumbai University
Mumbai, India01-2001
Skills
- Base SAS Programming & SAS Macros
- Clinical Trial Data Analysis (Phase I–IV)
- TLF Development & Validation
- Data Validation & Quality Control
- Programming Specifications & Documentation
- Vendor Oversight & Deliverable Review
- Clinical Data Review & Issue Resolution
- Statistical Programming & Analysis
- CDISC Standards (SDTM & ADaM)
- Regulatory Submission Support (FDA/EMA)
- SAS SQL, SAS/STAT, SAS/ODS & SAS/Graph
- Cross-Functional Collaboration
- Project Planning
- Process Improvement & Automation
- SAS coding
- Proficient in Base SAS, SQL, Macros, SAS/STAT, SAS/Graph, and SAS/ODS
- Expertise in CDISC-SDTM and ADaM standards implementation
- Strong hands-on experience in SAS programming for clinical trial data analysis (Phase I - IV)
- Clinical Trial Phases
- In-depth knowledge and experience in all phases of clinical trials
- Data standards compliance
- Proficient in generating datasets, tables, listings, and figures (TLF) in accordance with CDISC standards
- Communication: Strong communication skills with the ability to collaborate effectively with cross-functional teams
- Leadership: Coordinated and managed statistical programming activities Led multiple studies and played a key role in building and mentoring teams
- Mentorship: Extensive experience in mentoring, recruiting, and team supervision Successfully set up and managed new teams
- Problem Solving: Quick learner with an eye for detail and excellent problem-solving skills
- Analytical thinking
- Predictive modeling
- Statistical quality assurance
- Strong analytical skills
- Collaborative team player
Certification
SAS Base Programming Certification for SAS9, earned in 2008.
Personal Information
- Title: Statistical SAS Programmer, California
- Work Permit: Authorized to work for any US employer
Timeline
Sr. Statistical Programmer II
AstraZeneca Pharmaceuticals
09.2020 - Current
Sr. Statistical Programmer Consultant
Ideal Consultant LLC.
02.2020 - 03.2020
Principal Stat Programmer
inVentiv Health
03.2016 - 02.2017
Statistical Programmer - Asst. Manager
Accenture Service Pvt Ltd.
08.2010 - 03.2016
Sr Statistical Programmer
PharmaNet Clinical Services
06.2007 - 08.2010
Associate Clinical Programmer
Pfizer Pharmaceutical Pvt Ltd
12.2006 - 05.2007
Statistical Analyst
Novartis Healthcare Pvt. Ltd.
06.2006 - 12.2006
Executive –Biometrics
Reliance Clinical Research Services Pvt. Ltd.
01.2004 - 05.2006
Bachelor of Science (BSc) - Statistics
Mumbai University
Master of Science (MSc) - Statistics
Mumbai University