Clinical Data Science - SDTM, ADaM | Pharmaceutical Science | ex - Novo Nordisk

Pune District, Maharashtra, India

Bengaluru, Karnataka, India

Pune District, Maharashtra, India

Pune Division, Maharashtra, India




Master of Business Administration - MBA
Manipal Academy of Higher Education

Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences
Pune university
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Experienced Clinical Trial Data Professional with 3 years of experience across multiple therapeutic areas. Backed by a foundation in Pharmaceutical Sciences, I bring strong clinical understanding to deliver accurate, regulatory-compliant data outputs. Core Expertise • CDISC & Compliance: Strong experience in SDTM development with working knowledge of ADaM standards. • Regulatory Submissions: Hands-on expertise in submission-ready XPTs, SDTM mapping specs, define.xml, annotated CRFs, and cSDRGs, ensuring Pinnacle 21 compliance. • Data Integration: Proficient in integrating complex external data sources including eCOA, Central Labs, and Medical Devices. • Quality Focus: Recognized by VP-level leadership for high-quality delivery and compliance excellence. Technical Skills • SAS Programming: Base SAS, SAS/SQL, and Macro Programming for efficient data manipulation and automation. • Expanding Skillset: Actively building proficiency in Python and R to support modern data workflows. • Tools & Platforms: SAS EG, Power BI, Pinnacle 21, PyCharm. Professional Approach I combine technical precision with a collaborative mindset, communicating risks and data anomalies clearly to stakeholders. Driven by continuous learning and curiosity, I focus on delivering high-impact, compliant, and reliable clinical data solutions.
Pune District
antigravity
gemini
lovable
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Master of Business Administration - MBA, Manipal Academy of Higher Education
Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences, Pune university