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Fsp Principal Biostatistician – Early Phase Clinical Development (Pk)

3-5 years
$115,900 – $243,900
10 Sept. 9, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/ B.Pharma/ M.Pharma/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

FSP Principal Biostatistician – Early Phase Clinical Development (PK)
📍 Durham, North Carolina (Home-based in the U.S. or Canada)
🕒 Full-Time
📄 Job ID: R1478711
🌍 Available in additional locations


Company Overview

IQVIA’s Data Sciences Staffing Solutions (DS3) delivers fully embedded resources via Functional Service Provider (FSP) partnerships. Working directly within sponsor teams and systems, DS3 supports world-class pharmaceutical and biotech clients to accelerate drug development and bring new therapies to market.

🌐 Learn more: https://jobs.iqvia.com


Why Work with DSSS?

  • Remote, home-based work opportunities

  • Work/life balance with flexible schedules

  • Collaboration with motivated, high-performance statistical and research teams

  • Technical training and tailored development curriculum

  • Research projects aligned with your skillset

  • Promising career growth and trajectory

  • Long-term job stability and re-deployment opportunities

  • Focus on advancing new therapies rather than project budgets

  • Engaging, fast-paced work environment


Job Summary

Provide statistical support for early phase drug development programs, primarily focusing on healthy volunteer studies with pharmacokinetic (PK) and pharmacodynamic (PD) endpoints.


Key Responsibilities

  • Collaborate with multidisciplinary project teams to establish timelines

  • Provide statistical input for study synopses and protocols

  • Write statistical sections of clinical trial protocols, including sample size calculations

  • Review eCRF and other data management documents

  • Create or review randomization schemes and related specifications

  • Write or review statistical analysis plans (SAP), dataset, and tables/listings/figures (TLF) specifications

  • Guide and supervise programmers in dataset authoring and programming of TLFs

  • Perform statistical review and validation of datasets and outputs

  • Use SAS and/or R to perform inferential analyses and validate key data derivations

  • Interpret study results and review accuracy of study reports

  • Monitor internal and CRO project activities including timelines and deliverables

  • Collaborate with Data Management, Clinical Development, and Clinical Pharmacologists/PK teams

  • Contribute to clinical study reports and other regulatory documents (e.g., DSURs, Investigator Brochures)

  • Support exploratory analyses and may assist in IND-related activities


Minimum Qualifications

  • PhD in Statistics, Biostatistics, or related field with 3+ years industry experience

  • OR MS in Statistics, Biostatistics, or related field with 5+ years industry experience

  • Minimum 2 years experience analyzing non-compartmental PK endpoints in the pharmaceutical industry

  • Understanding of ICH GCP, clinical pharmacology regulatory guidance, and industry standards

  • Experience with CDISC standards including SDTM, ADaM, CDASH

  • Ability to work independently with strong project management and decision-making skills

  • Effective communication skills and ability to manage programmers constructively

  • Proficiency in SAS for performing analyses and data validation


Desired Experience

  • Knowledge of basic statistical modeling, simulations, and PD/biomarker analyses


Compensation & Benefits

💰 Annual Salary Range:
$115,900 – $243,900 (varies by qualifications, experience, location, schedule)

Additional benefits may include incentive plans, bonuses, health and welfare programs.


Work Environment

🏠 Home-based (Remote work) in the U.S. or Canada


Equal Employment Opportunity

IQVIA is an equal opportunity employer committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other protected status.

🔗 EEO Policy


How to Apply

🔗 Apply Now