Sunil Babu P.

As Lead Statistician at Novo Nordisk, I directed global statistical operations for clinical and Omics trials, integrating advanced analytics, automation, and regulatory compliance to strengthen the scientific integrity and efficiency of submissions. Leveraging expertise in R and Python, I drove end-to-end statistical planning, data integration, and deliverable oversight, ensuring high-quality analyses aligned with CDISC standards, FDA/EMA requirements, and clinical study objectives. Directed the proteomics data acquisition lifecycle, implementing stringent data validationand quality control (QC) standards for vendor-sourced data (e.g., SomaLogic, Olink) Directed design and integration of trial metadata with Omics datasets, establishing traceable preprocessing pipelines and reproducible analytical workflows. Authored and reviewed Statistical and Proteomics Analysis Plans (SAPs, ProteOAPs), enhancing compliance, documentation clarity, and regulatory readiness Conducted high-impact statistical inference, including treatment effect volcano plots andpathway analysis, to robustly identify and characterize statistically signifi cant proteins Developed automated scripts and modular Omics app components, improving reproducibility, interactivity, and analytical throughput. Agile process improvements, optimizing analytical workfl ow effi ciency and continuous fl ow using Kanban methodologies

DSUR/PSUR Submissions, Trail Programmer & Statistician Blended role Led statistical monitoring and data review using interactive Power BI dashboards, enabling real-time oversight of study performance and data quality. Ensured accuracy and consistency across validated datasets, CSR outputs, and regulatory submissions (FDA/EMA), maintaining end-to-end quality assurance. Provided technical mentorship and strategic guidance to statisticians and programmers, elevating analytical standards and operational efficiency.

As Senior Biostatistician at IQVIA, I led statistical planning, programming, and regulatory submissions for medical device studies, ensuring FDA compliance, analytical precision, and end-to-end data standardization aligned with CDISC and organizational quality frameworks. Directed statistical activities supporting FDA medical device submissions, ensuring traceable, audit-ready deliverables and regulatory adherence. Collaborated closely with Novo Nordisk HQ during an LTA assignment in Søborg, Denmark, advancing cross-functional analytical alignment and data strategy. Led a team of 3 statisticians and 2 programmers, improving efficiency, analytical standards, and delivery timelines across concurrent global studies. Authored and reviewed Statistical Analysis Plans (SAPs), mock shells, and clinical report sections, bolstering submission readiness. Oversaw statistical programming, SDTM/ADaM mapping, and TLF generation, guaranteeing validated and submission-quality datasets. Partnered with clinical, regulatory, and data management teams to align statistical methodologies with study and submission goals. Mentored junior statisticians through structured learning sessions, strengthening technical rigor and process compliance across studies.

Directed SAS programming and data validation for Diabetes and Immunogenicity studies, ensuring accuracy, consistency, and audit-ready outputs. Contributed to HTA German dossier submissions, supporting regulatory and health technology evaluations through advanced statistical and risk-benefit analyses. Supported exploratory, ad-hoc, and submission analyses, ensuring timely and compliant responses to regulatory authorities.

As a Biostatistician in the Pharmacovigilance division, I supported global safety and regulatory reporting by delivering statistically sound analyses and standardized documentation. My role focused on enhancing data accuracy, visualization, and submission readiness for periodic safety updates and signal detection activities. Prepared biostatistical plans and reports aligned with global pharmacovigilance and regulatory submission standards. Developed and programmed Forest Plots in SAS for signal detection and DSUR submissions, providing clear statistical visualization of safety outcomes. Supported medical writing and regulatory teams through timely statistical inputs, ensuring compliance and audit traceability. Contributed to developing and maintaining Biostatistics and SAS SOPs, strengthening quality assurance and procedural consistency across reporting functions. EDC review regarding database designing (a-arisglobal tool).

Managing and mentoring Team Members. Identifying team metrics and projecting their performances. SOP preparations and attending department audits. Managed team resources while mentoring and training statisticians, enhancing team capability and knowledge sharing. Involving in QC activities and responsible for Overall QC for all final deliverables.

Contributed to the design, analysis, and submission of clinical trials, primarily in oncology, ensuring accuracy, compliance, and scientific robustness. Played a key role in developing datasets, performing quality control checks, and mentoring junior team members to maintain high delivery standards across statistical operations. Designed and analyzed oncology studies, including SDTM mapping, ADaM dataset creation, and generation of final TLFs for study submissions. Authored statistical methodologies and executed analyses for integrated study reports, ensuring alignment with regulatory submission requirements. Reviewed CRFs, annotated CRFs, and EDC specifications, collaborating closely with cross-functional teams to uphold data integrity and operational efficiency. Led QC activities and managed final quality checks for deliverables, maintaining consistency, accuracy, and compliance with SOPs.

Supports the writing of statistical analysis plans, including the definition of derived data sets, and the design of statistical tables, figures, and data listings for clinical summary reports. Carries out project related work in accordance with company standard operating procedures (SOPs). Supports the writing of statistical analysis plans, including the definition of derived data sets, and the design of statistical tables, figures, and data listings for clinical summary reports. Generating the randomized codes for clinical study designs using SAS. Carries out project related work in accordance with company standard operating procedures (SOPs). Review of CRF and aCRF as per the protocol and supporting the data management team. Prepares statistical summary reports under the supervision of senior bio-statisticians.

Worked as Research Investigator, for a study on HIV Vulnerability - a cohort study, under some exploratory purpose on HIV patients. Provided biostatistical and analytical support for public health and women’s health research, contributing to studies on HIV risk assessment Using Atlas qualitative analytical tool to fetch data Developed and maintained research databases and contributed to statistical writing for peer-reviewed publications, enhancing the quality and credibility of research outputs. Data Collection in the field for both Base-line and Follow up.

Supported for a project for understanding the causes of infertility in female group and their diagnosis Questionnaire Desigining & validation using PCA-Factor Analysis, ensuring the accuracy and reliability of research instruments.

Worked as a Research Investigator for a project on Epidemology project for client "Population Council - New Delhi " on HIV Vulnerability.

Ongoing

Completed PGDBM in Distance Education mode

Played for Stat Department Cricket Team as Vice-Captain and Runner-up for the inter-departmental trophy Cultural activist and acted major roles in departmental functions and involved in organizing department seminars and webinars