Soma Sekhar S.

About Soma Sekhar S.

Gen-AI: AZ-ChatGPT Licensed User: with hands-on experience co-piloting in statistical programming, standards reviews, gap analysis wrt Industry standards to enhance efficiency, accuracy and productivity. Skilled in prompt engineering and leveraging AI: for the automation of routine tasks and statistical programming workflow optimization. Regulatory Submissions Programming: Phase Breast Studies (Dato-DXd):Led TROPION-Breast 01 study statistical programming for BLA submissions to FDA, PMDA, and EMA. Pooling Programming Lead (Lynparza):Led sNDA submissions to FDA, ensuring compliance and accuracy. Regulatory Inspection Representation:Represented the statistical programming team during FDA, PMDA, and EMA inspections for Tropion Breast-01 Dato-DXd. Project-Statistical Programming : Hematology (Empliciti, BMS):Led development and regulatory submissions for ELOQUENT-3 Phase II study to FDA. Psoriasis Studies (Sotyktu, BMS):Managed DBL, HLR readouts, and e-submission activities for POETYK PSO-1 and POETYK PSO-2. Presentations and Communication: Delivered over 10 presentations at international conferences, including PHUSE Connect, CDISC and FDA/CSS. Advanced Programming Skills: Proficient in SAS, R, and Python. Conducted comparative analysis of statistical results and developed automation tools. Led CAMIS Onco-PHUSE Working Group, focusing on multi-lingual programming. CDISC and Regulatory Standards: Working in Oncology TA Standards development and management Team. With focus on SDTM, ADaM and Table reporting: oncology Analysis and Reporting standards.

Experience

1. Statistical Programming, Therapeutic Area Standards and Automation Leader - Oncology (Interim)

   AstraZeneca

   May 2024 — Present · Gaithersburg, MD, US

   Acting as Team Lead - Oncology Analysis and Reporting Standards.Lead Cross Functional team of Stats and Clinicians to develop, govern standards Develop and implement end-to-end Oncology standards across AstraZeneca, ensuring consistency and innovation.Provide strategic leadership to Biometrics teams for effective TA and study-level standards.Drive risk analysis and mitigation, ensuring compliance with AstraZeneca, CDISC, and regulatory standards.Oversee SDTM, ADaM, and TLF programming standards for quality regulatory and scientific outputs.Recruit, mentor, and develop standards developers and SME Champions NetworkReview and implement SOPs to enhance efficiency and compliance.

Education

• Kansas State University

  Masters Degree with Graduate Certificate

• Harvard University

  Harvard Catalyst - Ceritificate