Principal Pharmacometrician, FSP

IQVIA•Durham, NC

19d•Remote

About The Position

Data Sciences Staffing Solutions, DSSS or DS3, is a unit within IQVIA that provides our sponsors with fully dedicated resources through a Functional Service Provider (FSP) partnership. This affords all the benefits of working for an industry leading global CRO while operating within a sponsor team and utilizing sponsor systems. These sponsor clients include world class pharmaceutical and biotech companies, offering you a unique opportunity to work on a team where your role is both challenging and rewarding, alongside colleagues who are passionate about influencing the future of medicine and advancing therapies. With IQVIA's DSSS, you become a core part of a dynamic team dedicated to reshaping the future of healthcare. Additional Benefits: Home-based, remote work opportunities. Work/life balance. Collaborate on projects and innovations with industry leaders in the Pharma and CRO sectors. Cohesive team environment fostering a collaborative approach to study work. Variety of therapeutic areas, indications and, study phases. Job stability; long-term engagements and development opportunities. Career advancement opportunities.

Requirements

PharmD, Ph.D. (or equivalent) in pharmacology, pharmacy, pharmacometrics, pharmaceutics, biology, mathematics, statistics, engineering, or a field with significant modeling-related content/training required
Minimum of 3 years’ experience in Pharmacokinetics or Pharmacology for Clinical Research Organization or pharmaceutical environment
Minimum of 2 years in applying model-based methods in pre-clinical and clinical drug development
Expert knowledge of pharmacometric concepts, including compartmental and noncompartmental analysis, population PK modeling, current therapeutic environment, and drug development trends.
Scientific skills demonstrated in facilitating the (early/full) clinical development strategy
Strong understanding of the principles of the drug development process, ICH GCP, and applicable international and national regulatory requirements
Good problem solving and analytical skills
Excellent computer skills, including proficiency with Microsoft Office, WinNonlin, and graphing, as well as NONMEM, R, and basic SAS programming
Excellent verbal and written communication skills and highly effective interpersonal, and organizational skills
Ability to prioritize, and independently coordinate and manage PK/PD component of complex projects
Ability to interact in a cross-functional and multi-cultural team environment
Ability to establish and maintain effective working relationships with coworkers, managers and clients

Responsibilities

Contribute to development of protocols, analysis plans, PK/PD analysis, and pharmacometric reports for pre-clinical or Phase I-IV clinical studies.
Consult with Clinical Pharmacology staff on study design, analyses, clinical development plans.
Plan and execute a wide range of pharmacometric analyses to inform clinical pharmacology and drug development decisions
Prepare or review PK/PD sections of dossiers for product registration and communicate with regulatory agencies.
Assess pharmacometric requirements for and ensure integration of pharmacometric information into drug development milestones and development decisions.
Ensure quality and timely delivery of project PK/PD deliverables.
Collaborate in cross functional teams that include Project Manager, CRA, Data Manager, Biostatistician, Programmer, and/or Medical Writer.
Maintain awareness of overall developments in the field of pharmacometrics and clinical pharmacology, based on current literature, application of new technology, attendance at professional meetings, etc.

Benefits

Home-based, remote work opportunities.
Work/life balance.
Collaborate on projects and innovations with industry leaders in the Pharma and CRO sectors.
Cohesive team environment fostering a collaborative approach to study work.
Variety of therapeutic areas, indications and, study phases.
Job stability; long-term engagements and development opportunities.
Career advancement opportunities.

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