Sunil Malavalli Kusha
Summary
Certified Base SAS Programmer with over 13 years of IT and clinical development experience, including 11+ years specializing in Clinical Trials data analysis and reporting using SAS and R. Recognized for consistently delivering high-quality outputs for leading pharmaceutical organizations such as Novartis and GSK. Possess strong expertise in CDISC standards (SDTM and ADaM), with extensive experience in TLF generation, ISS/ISE preparation, CRF review, TLF shell development, ADRG, and SDRG authoring. Demonstrated proficiency across all phases of clinical trials (Phase I–IV) within diverse therapeutic areas including Infectious Diseases, Cardiovascular and Renal Metabolism (CRM), Respiratory, Immunology, and Oncology, ensuring compliance with ICH-GCP guidelines and organizational SOPs.
Experienced in leading and supporting FDA and EMA regulatory submission studies, providing statistical programming leadership, technical guidance, and innovative solutions to complex study requirements. Additionally, contributed to process and quality improvements by developing R Shiny applications and dashboards to enhance lead programmer oversight, streamline review processes, improve operational efficiency, and strengthen the overall quality of deliverables. Recognized for strong project leadership, advanced problem-solving skills, effective planning, clear communication, and successful execution of clinical programming deliverables.
Overview
3
3
Languages
13
13
years of professional experience
Work History
Assoc Principal Statistical Programmer
IQVIA RDS GMBH
Düsseldorf, Germany
08.2022 - Current
- Led statistical programming activities as Project Programmer (PP) and Trial Programmer (TP), managing a team of 15 members and overseeing project planning, resource allocation, status tracking, and stakeholder communication.
- Developed sponsor-specific macros to automate ADaM and TLF generation processes, enhancing workflow efficiency and quality.
- Possess extensive work experience in handling ADaM, SDTM, Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) studies.
- Reviewed SAP/RAP and created TLF shells while confirming the availability of all required mocks in SAP for TLF programming.
- Contribute to the department recruitment/candidate interview process.
- Created R Shiny applications to support lead programming activities, enabling efficient study tracking, review management, quality monitoring, and data-driven decision-making across clinical projects.
- Generated Define.xml and ADRG documents for regulatory submissions, ensuring compliance and accuracy.
- Created TLFs (Table, Listings, and Figures) and delivered training sessions using R to enhance team capability and project outcomes.
- Led and accountability for overseeing programming activities, including analysis datasets, pooled datasets, listings, tables, and figures, across Phase I-IV clinical trials. Managed both single-indication studies and large trials, coordinating parallel activities to support programmers and statisticians in project-level tasks and handled Biomarker and HTA requests.
Principal Statistical Programmer
PAREXEL INTERNATIONAL
Bengaluru
04.2022 - 07.2022
- Serve as a lead programmer or project lead on studies or drug programs of all complexities and size scales.
- Work directly with project team leaders and client representatives to conduct team meetings, develop and maintain project timelines, assess, and forecast resources, and ensure adherence to study budgets and any relevant contractual obligations or limits with clients.
- Increases knowledge base and professional skills for self and junior team members, in areas including programming technology and techniques, clinical trials, and developments in the pharmaceutical industry.
- Provide feedback to managers on employee performance for employee development, performance reviews and training.
- Thrive in a fast-paced environment, managing multiple projects simultaneously with outstanding efficiency.
Senior Statistical Programmer
PAREXEL INTERNATIONAL
Bengaluru
01.2020 - 03.2022
- Spearheaded programming operations as Lead Statistical Programmer.
- Drove programming support, enhancing study documentation quality.
- Orchestrated management of analysis datasets and statistical outputs (Tables, Listings, and Figures - TLFs).
- Uphold stringent compliance with industry standards across projects.
- Provided pivotal support to project teams across various clinical trial phases.
Statistical Programmer II
PAREXEL INTERNATIONAL
Bengaluru
11.2017 - 12.2019
- Executed programming for clinical trials, encompassing data sets, listings, and statistical tables.
- Played a key role in regulatory submission processes through advanced programming contributions.
- Spearheaded the development of macros to enhance efficiency and accuracy in statistical analysis.
Statistical Programmer I
PAREXEL INTERNATIONAL
Bengaluru
08.2015 - 10.2017
- Facilitated programming operations and generated Tables, Listings, and Figures (TLFs) for data analysis.
- Played a key role in developing study documentation and adhering to data standards.
Software Engineer
FINCURO SOLUTIONS PVT. LTD
Bengaluru
09.2013 - 04.2015
- Developed SAS-based solutions for banking domain, enhancing financial reporting capabilities.
- Spearheaded the creation of banking reports, optimizing data analysis and decision-making processes.
Education
BACHELOR OF ENGINEERING (B.E) -
VISVESVARAYA TECHNOLOGICAL UNIVERSITY
Belgaum, India01-2012
Skills
- SAS 94
- SAS
- R STUDIO
- R Shiny
- PINNACLE 21 ENTERPRISE
- ADAM VALIDATION
- TSCG
- HARP
- REPORTING
- GPSII
- LINUX
- WINDOWS
Languages
English
Proficient
C2
German
Elementary
A2
Kannada
Proficient
C2
Hobbies
- Sports
- Painting
Timeline
Assoc Principal Statistical Programmer
IQVIA RDS GMBH
08.2022 - Current
Principal Statistical Programmer
PAREXEL INTERNATIONAL
04.2022 - 07.2022
Senior Statistical Programmer
PAREXEL INTERNATIONAL
01.2020 - 03.2022
Statistical Programmer II
PAREXEL INTERNATIONAL
11.2017 - 12.2019
Statistical Programmer I
PAREXEL INTERNATIONAL
08.2015 - 10.2017
Software Engineer
FINCURO SOLUTIONS PVT. LTD
09.2013 - 04.2015
BACHELOR OF ENGINEERING (B.E) -
VISVESVARAYA TECHNOLOGICAL UNIVERSITY