Principal Pharmacometrician, FSP

IQVIA; Durham (NC); Remote; USD 105,000 - 295,000; Full time

Job summary

A leading global CRO is seeking an FSP Principal Pharmacometrician to work remotely. You will contribute to the development of protocols and analyses for clinical pharmacology studies, collaborating with cross-functional teams. The ideal candidate holds a PharmD or Ph.D. with at least 3 years in Pharmacokinetics or Pharmacology. Strong analytical and communication skills are essential for this role which offers competitive compensation and opportunities for advancement.

Benefits

Home-based work opportunities

Work/life balance

Collaborative team environment

Job stability

Career advancement opportunities

Qualifications

• Minimum of 3 years’ experience in Pharmacokinetics or Pharmacology.
• Strong understanding of drug development process and regulatory requirements.
• Ability to manage complex projects independently.

Responsibilities

• Develop protocols and statistical analysis plans for clinical studies.
• Consult on study design and clinical development plans.
• Review analyses and documents to ensure accuracy.
• Collaborate with cross-functional teams.
• Maintain awareness of developments in Clinical Pharmacology.

Skills

Pharmacometric concepts

Problem solving

Analytical skills

Communication skills

Computer skills

Education

PharmD or Ph.D. in related field

Tools

Microsoft Office

WinNonlin

NONMEM

R

SAS programming

Job description

Job Level: FSP Principal Pharmacometrician

Location: Home-based in the U.S.or Canada

Why DSSS?

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.

Responsibilities:

• Contribute to development of protocols, statistical analysis plans, PK/PD analysis, PK/PD tables, listings and figures, and clinical study reports for Phase I-IV clinical pharmacology studies, such as dose tolerance, dose proportionality, mass balance, concept testing, bioavailability, thorough QTc, drug-drug interactions, and special population (age effects, renal disease, hepatic disease, gender effects, etc.), as well as population PK/PD studies.
• Consult with Clinical Pharmacology staff on study design, clinical development plans.
• Review analyses and documents prepared by CROs to help ensure accuracy and appropriateness.
• Prepare or review PK/PD sections of dossiers for product registration and communicate with regulatory agencies.
• 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 Clinical Pharmacology and PK/PD based on current literature, application of new technology, attendance at professional meetings, etc.

Qualifications:

• PharmD, Ph.D. in Pharmacology, Pharmacy, Pharmacokinetics, Pharmaceutics, Biology, or similar required
• Minimum of 3 years’ experience in Pharmacokinetics or Pharmacology for Clinical Research Organization or pharmaceutical environment
• Expert knowledge of pharmacometric concepts, including noncompartmental analysis and population PK modeling, current therapeutic environment, and drug development trends
• 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.

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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more athttps://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

The potential base pay range for this role, when annualized, is $105,800.00 - $294,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.