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venky naidu

@venkynaidu

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Biostatistical Programmer with expertise in clinical data analysis.

India

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What I'm looking for

I am seeking a challenging role that allows me to leverage my skills in data analysis and formulation development while contributing to innovative projects in the pharmaceutical industry.

I am a dedicated Biostatistical Programmer with a strong background in clinical trial data analysis and a commitment to achieving organizational objectives. My experience at IQVIA Pvt Ltd involved meticulous data cleaning and analysis, ensuring high accuracy for FDA submissions. I excel in building CRF annotations and generating tables and listings that adhere to CDISC standards, all while maintaining a zero-error log in production.

Prior to my role at IQVIA, I served as a Senior R&D Scientist at Leiutis Pharmaceuticals, where I led the development of injectable formulations and conducted extensive stability studies. My academic background includes teaching at Bhaskar Pharmacy College, where I honed my communication skills and developed a passion for mentoring future pharmacists. I am also well-versed in regulatory compliance and quality risk assessments, ensuring that all projects meet stringent industry standards.

Experience

Work history, roles, and key accomplishments

Biostatistical Programmer

IQVIA Pvt Ltd

Jul 2018 - Present (7 years)

Analyzed clinical trial data using advanced cleaning techniques and edit checks to ensure high accuracy for FDA submissions. Developed CRF annotations and Metadata according to trial protocols and therapeutic areas, building safety and efficacy domains with SAS and SDTM-CDISC standards.

Data Cleaning SAS CDISC Debugging Metadata

Sr. R&D Scientist (Injectables)

Leiutis P.ceuticals

Jun 2015 - Present (10 years 1 month)

Conducted literature searches and comparative studies for RLD, establishing physical and chemical parameters for trial batches. Executed lab-scale R&D trial batches for various dosage forms, including injections and lyophilized preparations, while handling formulation equipment.

Lyophilization

Asst. Professor

Bhaskar Pharmacy College

Dec 2013 - Present (11 years 7 months)

Taught pharmaceutics and related subjects, including practical lab work, to students. Prepared SOPs, lab manuals, and regulatory documents for AICTE, PCI, and University compliance.

Teaching SOP Development Regulatory Compliance AICTE PCI University Regulations

Claims Associate

United Health Group

Oct 2011 - Present (13 years 9 months)

Processed insurance claims in strict adherence to HIPPA guidelines. Utilized ICD-10 coding to ensure accurate and compliant claim submissions.

ICD 10 Coding Data Entry Compliance

Education

Degrees, certifications, and relevant coursework

Sree Venkateswara University

Master of Pharmacy, Pharmaceutics

Studied advanced concepts in Pharmaceutics, focusing on drug formulation and delivery systems. Gained expertise in pharmaceutical research and development.

Sree Vidyanikethan College of Pharmacy

Bachelor of Pharmacy, Pharmacy

Completed a Bachelor's degree in Pharmacy, covering fundamental principles of pharmaceutical sciences. Developed a strong foundation in drug discovery, development, and patient care.