Principal Clinical SAS Programmer Swaruparani Kolla recently marked her 11-year anniversary of critical contributions in clinical trial data highlighted by years of increasing responsibilities in some of the world’s largest CROs and pharmaceutical companies. She leads a team of SAS programmers across the globe, managing projects and ensuring they meet quality and timeline goals.
Kolla is a standout performer in her field who has distinguished herself through academic training and extensive field experience. Unlike other colleagues in her field who typically have limited their academic studies to statistics or pharmacy, Swarupa has a master’s degree in Regulatory Affairs and a Bachelor of Science in Pharmacy, further boosted by certifications in SAS software, specifically Base SAS and Clinical SAS. She began her academic journey in her native India where she earned a Bachelor’s degree in Pharmacy from Annamalai University. This foundational education equipped her with a deep understanding of physiology, biology, human anatomy, and chemistry.
This educational background differentiates her from her colleagues as she brings a deep understanding of the four phases of clinical trials namely drug interactions, patient safety, dosage regimens, and regulatory agencies. This expertise enables her to more effectively interact with diverse teams involved in drug development, from researchers to medical writers, statisticians and doctors. It also helps her be more effective in identifying the safety and efficiency of a drug in treating the target condition, and any side effects.
Additionally, her advanced degree in Regulatory Affairs provides Kolla an in-depth knowledge of FDA regulations and prerequisites for FDA submissions, such as the Investigational New Drug (IND) and New Drug Application (NDA) processes. Her knowledge in International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and Good Clinical Practice (GCP) guidelines have proven indispensable in her daily professional endeavors.
Kolla’s undergraduate studies equipped her with a deep understanding of physiology, biology, human anatomy, and chemistry, significantly contributing to her understanding of the intricate interplay between pharmaceutical drugs and the human body, encompassing vital aspects like drug absorption, distribution, metabolism, and excretion.
Some of the therapeutic areas she has worked on include oncology, infectious diseases (COVID- 19, malaria), and immunology. She is responsible for developing programming strategies, standards, specifications and resolving any escalating data issues. Kolla also creates and validates several Safety & Efficacy ADaM datasets as per CDISC Standards (official standards for submitting clinical trial results to FDA).
One of the highlights of her career was working on clinical trials for the global pandemic COVID- 19. She specifically with colleagues from around the world under very tight deadlines on COVID- 19 booster vaccine development for all the variants including the lethal Delta variant. Her analysis work helped define resist criteria, survival rate analysis, and contributed to overall patient safety and drug efficiency.
In summary, Swarupa Kolla is an outstanding professional in the domains of clinical statistical programming and regulatory affairs. Her stellar academic journey, enriched by her pharmacy and regulatory affairs background, has been instrumental in her ability to guide drug development and safety assurance. Swarupa’s certifications and vast experience have amplified her impact, and her contributions to high-profile trials, including COVID and cancer studies, underscore her invaluable role in advancing public health and pharmaceutical science.