Instagram
youtube
Facebook

Principal Biostatistician, Functional Service Provider (Fsp) - R Regulatory Submission & Multiple

2 years
$131,300 โ€“ $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:

Principal Biostatistician, Functional Service Provider (FSP) - R Regulatory Submission & Multiple Imputations
๐Ÿ“ Durham, North Carolina (Home-based in the U.S. or Canada)
๐Ÿ•’ Full-Time
๐Ÿ“„ Job ID: R1451351
๐ŸŒ Job available in additional locations


Company Overview

IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries. Data Sciences Staffing Solutions (DSSS) delivers fully embedded resources through Functional Service Provider (FSP) partnerships, enabling direct collaboration with cross-functional sponsor teams from world-class pharmaceutical and biotech companies.

๐ŸŒ Learn more: https://jobs.iqvia.com


Why DSSS?

  • Home-based remote work opportunities

  • Work/life balance and flexible schedules

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

  • Access to technical training and tailored development curriculum

  • Research projects matching your unique skillset

  • Promising career trajectory with long-term engagements and re-deployment opportunities

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

  • Engaging and fast-paced work environment


Job Summary

Provide comprehensive statistical support for clinical trials involving patients, focusing on regulatory submissions and multiple imputation analyses.


Key Responsibilities

  • Collaborate with multidisciplinary teams to establish project objectives and timelines

  • Write statistical sections for clinical trial protocols in consultation with internal and external experts

  • Develop statistical analysis plans (SAPs)

  • Monitor internal and CRO project activities, including timelines, deliverables, and resources

  • Collaborate with Data Management, Clinical Development, and Clinical Operations providing statistical expertise

  • Contribute to clinical study reports and regulatory documents such as DSURs and Briefing Documents

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

  • Interpret study results and review reports for accuracy

  • Support exploratory analyses and medical affairs publications

  • Participate in pre-IND and NDA activities

  • Engage in other activities and meetings to support Biostatistics and Development Teams as required


Minimum Qualifications

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

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

  • Minimum 3 years of experience with Phase 2/3 clinical trials

  • Demonstrated ability to independently manage projects and make decisions

  • Effective communication skills and ability to manage programmers constructively

  • Proficiency in R for efficacy and safety analyses and data validation

  • Understanding of ICH GCP, ICH E9, and general industry practices and standards

  • At least 2 years supporting multiple imputation analyses

  • Experience with CDISC standards including SDTM, ADaM, and CDASH


Desired Experience

  • Interaction experience with regulators, including Advisory Committee meetings

  • 2+ years of experience in Immunology therapeutic area and regulatory submissions


Compensation & Benefits

๐Ÿ’ฐ Annual Salary Range:
$131,300 – $243,900 (varies by qualifications, experience, location, and schedule)

Additional benefits may include:

  • Incentive plans and bonuses

  • Health and welfare benefits


Work Environment

๐Ÿ  Home-based (Remote work) within the U.S. or Canada


Equal Employment Opportunity

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

๐Ÿ”— EEO Policy


How to Apply

๐Ÿ”— Apply Now