Sr Pharmacokineticist

Syneos Health; Hyderabad; On-site; INR 4,000,000 - 6,000,000; Full time

Job summary

Syneos Health in Hyderabad, India, seeks a pharmacometrics specialist to act as a scientific and technical resource in PK/PD analyses and perform complex PK/PD analyses across clinical and nonclinical projects.

You will calculate PK parameters, perform statistical analyses on bioanalytical and clinical data with validated software, and write PK/statistical sections of reports with interpretation of results for regulatory submissions.

Qualifications

• Strong knowledge of PK/PD with experience in clinical or nonclinical reporting.
• Proficiency in validated software for PK/PD analysis.
• Ability to design studies and interpret PK/PD results for reports.

Responsibilities

• Act as a scientific and technical resource person within Syneos Health for the pharmacokinetics and pharmacodynamics fields and perform complex pharmacokinetic and/or pharmacodynamic analyses.
• Calculate pharmacokinetic parameters and perform statistical analyses on bioanalytical and clinical (or nonclinical) data using tested or validated software
• Write the pharmacokinetic and statistical sections of clinical (early and late phases) or nonclinical (toxicokinetic studies) reports including interpretation of the results
• Participate in intra and/or extra company scientific consultancy
• Answer to deficiency letters from regulatory agencies on the conduct of the pharmacokinetic and statistical analyses performed during clinical studies
• Participate to the quotation process for the functional area activities using internal database, literature data and pricing grid
• Review study protocol in accordance with regulatory requirements using internal and/or literature data, and design information appearing in inhouse database.
• Write/review standard operating procedures related to his/her work
• Use quantitative approaches to integrate knowledge of PK, PD, efficacy, safety, patient demographics, and pathophysiological factors to facilitate product development and decision making under the supervision of pharmacometricians
• Participate in the development of structured and standardized data modeling practices and related SOPs
• Act as a consultant in clinical pharmacology study design development (e.g., optimal sampling, protocol review, etc.)
• Perform comprehensive quality control/peer review procedures

Skills

Pharmacokinetics

Pharmacodynamics

Statistical analysis

Clinical pharmacology

Regulatory submissions

Job description

Job Responsibilities

• Act as a scientific and technical resource person within Syneos Health for the pharmacokinetics and pharmacodynamics fields and perform complex pharmacokinetic and/or pharmacodynamic analyses.
• Calculate pharmacokinetic parameters and perform statistical analyses on bioanalytical and clinical (or nonclinical) data using tested or validated software
• Write the pharmacokinetic and statistical sections of clinical (early and late phases) or nonclinical (toxicokinetic studies) reports including interpretation of the results
• Participate in intra and/or extra company scientific consultancy
• Answer to deficiency letters from regulatory agencies on the conduct of the pharmacokinetic and statistical analyses performed during clinical studies
• Participate to the quotation process for the functional area activities using internal database, literature data and pricing grid
• Review study protocol in accordance with regulatory requirements using internal and/or literature data, and design information appearing in inhouse database.
• Write/review standard operating procedures related to his/her work
• Use quantitative approaches to integrate knowledge of PK, PD, efficacy, safety, patient demographics, and pathophysiological factors to facilitate product development and decision making under the supervision of pharmacometricians
• Participate in the development of structured and standardized data modeling practices and related SOPs
• Act as a consultant in clinical pharmacology study design development (e.g., optimal sampling, protocol review, etc.)
• Perform comprehensive quality control/peer review procedures