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@pradeeppatil
Experienced Senior Biostatistician with a passion for clinical research.
I am an experienced Senior Biostatistician with over 12 years of expertise in managing pharmacokinetic studies and collaborating on clinical research projects. My journey in the pharmaceutical industry has equipped me with a solid foundation in preparing Clinical Study Reports (CSRs) for various phases of clinical trials, ensuring compliance with regulatory requirements and guidelines such as ICH E3 and ICH GCP E6.
Throughout my career, I have honed my skills in medical writing, project management, and data presentation. I have successfully contributed to the preparation and review of essential documents, including study protocols, informed consent forms, and regulatory submissions in eCTD format. My experience with tools like Veeva Vault and ISI Toolbox has further enhanced my ability to deliver high-quality documentation within tight timelines.
As a self-driven and motivated professional, I am passionate about continuous learning and improvement. I thrive in collaborative environments where I can contribute to team objectives and take on new challenges. I am eager to leverage my skills and experience to become a valuable asset in a dynamic organization.
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Work history, roles, and key accomplishments
Teva Pharmaceuticals
Mar 2014 - Present (11 years 8 months)
Prepared Clinical Study Reports (CSR for Phase I, Phase IV and BA/BE study) within proposed timelines, adhering to raw data and regulatory requirements. Demonstrated knowledge of ICH E3 and ICH GCP E6 guidelines, utilizing Veeva Vault and GRIDS for CTD and eCTD document submissions. Managed eCTD processing, basic medical coding using MedDRA and WHO drug dictionary, and ensured document quality and
Teva Pharmaceuticals
Nov 2020 - Aug 2023 (2 years 9 months)
Prepared Clinical Study Reports (CSR for Phase I and BA/BE study) within proposed timelines, adhering to raw data and regulatory requirements. Handled preparation and review of aCSR/CSR, Appendices, OGD Tables, Module 2.7, and CS-BE Tables. Managed eCTD processing, prepared Study Protocol, Protocol Clarification letters, Amendments, Informed Consent Forms, and CRFs, and performed basic medical cod
Enem Nostrum Remedies Pvt. Ltd.
Nov 2019 - Nov 2020 (11 months)
Prepared Protocol, Informed Consent Documents (ICD), Case Report Form (CRF), Clinical Study Report, Study Summary Report, and Study updates. Performed OCR and review of eCTD study documents, and prepared SDTM & Clinic tables data with source documents. Resolved facility/study related QA/QC findings and conducted basic medical coding using MedDRA and WHO drug dictionary.
Accutest Research Laboratories Pvt. Ltd.
Oct 2018 - Nov 2019 (1 year 1 month)
Reviewed projects for submission to regulatory bodies including FDA, ANVISA, NDA, ANDA, EMEA, and in eCTD/ICH format. Prepared and reviewed regulatory submitted documents such as Annex-7, EU m 2.7.1, CSBE-Canada, and DBE summary tables. Prepared and reviewed clinical study reports, and effectively resolved queries from sponsors or regulatory bodies.
LifeSan Clinical Research
May 2016 - Oct 2018 (2 years 5 months)
Managed the receipt, storage, accountability, and dispensing of Investigational Medicinal Products (IMP), including archival/discard after study completion. Prepared protocol, study-specific ICF, CRF, and recruitment flyers. Performed OCR and review of eCTD study documents, acted as BMH/study coordinator, and compiled all essential documents for eCTD submission.
Anazeal Analytical and Research Pvt Ltd.
Dec 2014 - May 2016 (1 year 5 months)
Prepared protocol, ICF, and CRF, and submitted these documents to the Ethics Committee (EC) and sponsor. Prepared trial master files and pre-study checklists, and compiled MSR & other study files. Managed the receipt, storage, handling, accountability, and destruction of investigational product (IP), and was responsible for medication dispensing and IP dosing to subjects.
Degrees, certifications, and relevant coursework
Master of Pharmacy, Pharmacy
Completed a Master of Pharmacy degree at North Maharashtra University. Focused on advanced pharmaceutical studies and research methodologies.
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