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Principal Biostatistician, Functional Service Provider (Fsp) – Early Phase

5 years
$122,800 – $233,400
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:

Principal Biostatistician, Functional Service Provider (FSP) – Early Phase
📍 Durham, North Carolina (Home-based in the U.S. or Canada)
🕒 Full-Time
📄 Job ID: R1415305
🌍 Job available in additional locations


Company Overview

IQVIA’s Data Sciences Staffing Solutions (DSSS or DS3) provides fully embedded resources via Functional Service Provider (FSP) partnerships. Working within sponsor environments and systems, DSSS collaborates with leading pharmaceutical and biotech clients to advance innovative therapies to market.

🌐 Learn more: https://jobs.iqvia.com


Why DSSS?

  • Home-based remote work opportunities

  • Work/life balance with flexible schedules

  • Collaboration with high-performance statistical and research teams

  • Technical training and tailored development curriculum

  • Research projects matching unique skillsets

  • Promising career trajectory

  • Long-term engagements and re-deployment opportunities

  • Focus on advancing new therapies rather than project budgets and change orders

  • Experience with regulatory submissions

  • Fast-paced, engaging work environment


Job Summary

Provide statistical support for early-phase drug development programs, including dose escalation and efficacy assessments, primarily in oncology.


Key Responsibilities

  • Collaborate with multidisciplinary teams to establish project timelines

  • Provide statistical input for study protocols

  • Write statistical sections of clinical trial protocols, consulting internal and external experts

  • Develop statistical analysis plans (SAPs)

  • Monitor internal and CRO project activities, including timelines, deliverables, and resource availability

  • Collaborate with Data Management, Clinical Development, and Clinical Operations teams

  • Contribute to clinical study reports and regulatory documents (e.g., DSURs, Briefing Documents)

  • Guide and supervise programmers in dataset specifications and programming of tables, listings, and figures

  • Interpret study results and ensure accuracy of reports

  • Participate in authoring Clinical Development Plans

  • Support exploratory analyses and medical affairs publications

  • Participate in pre-IND and NDA activities

  • Engage in other Biostatistics and Development Team support activities as needed


Minimum Qualifications

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

  • OR MS in Statistics, Biostatistics, or related field with 7+ years industry experience

  • Early Phase Oncology experience preferred

  • Experience with dose escalation studies, efficacy endpoints, and solid tumors

  • At least 1 year of experience with regulatory submissions

  • Successful publication record

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

  • Strong communication skills and ability to manage programmers constructively

  • Proficient in SAS and/or R for efficacy analyses and data validation

  • Understanding of ICH GCP and industry standards

  • Experience with CDISC standards: SDTM, ADaM, CDASH


Desired Experience

  • Familiarity with R programming and other statistical software including EAST

  • Experience with Bayesian methods

  • Knowledge of simulations, multivariate analyses, and biomarker analyses


Compensation & Benefits

💰 Annual Salary Range:
$122,800 – $233,400 (dependent on qualifications, experience, location, and schedule)

Additional benefits may include:

  • Incentive plans and bonuses

  • Health and welfare benefits


Work Environment

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


Equal Employment Opportunity

IQVIA is an equal opportunity employer. All qualified applicants will receive consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other protected status.

🔗 EEO Policy


How to Apply

🔗 Apply Now