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Pharmacometrician at NTT DATA

Bengaluru, karnataka, India -

Full Time

Start Date

Immediate

Expiry Date

23 Mar, 26

Salary

0.0

Posted On

23 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Drug Development, Regulatory Requirements, Statistics, Modelling, Simulation, Problem Solving, Strategic Thinking, Conflict Resolution, Communication, Teamwork, Pharmacokinetics, Pharmacodynamics, Population PK Analysis, Software Proficiency, Clinical Pharmacology, Pharmacometrics

Industry

IT Services and IT Consulting

Description

Support design and analysis of clinical pharmacology studies. --- Maintain accountability for a culture of high customer service Conduct population PK and PK/PD analysis using appropriate software in collaboration with other pharmacometricians Review novel population PK analysis approaches to increase the efficiency and accuracy of population PK analysis Assist in the design as well as analyse/interpret clinical pharmacology studies (renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.); provide guidance to optimize pharmacokinetic sampling and dosing strategies Work with other pharmacometricians to prepare and review PK reports and other clinical pharmacology documents Provide inputs into clinical pharmacology and pharmacokinetic sections of regulatory documents, including INDs, NDAs, briefing packets, Investigator Brochures, etc Support client's nonclinical efforts to ensure that sufficient preclinical PK data exists to design and execute clinical studies Maintain current knowledge of advancements in PK and PK/PD science, regulatory guidance documents, FDA rulings, internal SOPs, and internal company guidance to be able to contribute ideas to improve technologies and procedures for PK practices --- Good understanding of clinical research, drug development, regulatory requirements and ICH guidelines Good understanding of statistics, modelling, simulation Focus on quality Good oral and written communication skills Teamwork and cooperation Effective at problem solving, strategic thinking, and conflict resolution --- Masters in pharmacy/life sciences or equivalent At least 2 years of experience in drug development, clinical pharmacology, and pharmacometrics Proficiency in NONMEM, Pirana, and R software preferred

Responsibilities

Support the design and analysis of clinical pharmacology studies while maintaining a high level of customer service. Conduct population PK and PK/PD analysis, assist in study design, and prepare regulatory documents.