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Associate/Director Of Biostatistics, Rare Disease, Fsp

8 years
$161,100 – $299,100
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:

Associate/Director of Biostatistics, Rare Disease, FSP
📍 Durham, North Carolina (Home-based in the U.S. or Canada, East Coast preferred)
🕒 Full-Time
📄 Job ID: R1461531
🌍 Available in additional locations


Company Overview

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. Through innovative partnerships and cutting-edge analytics, IQVIA accelerates the development and commercialization of medical treatments to improve patient outcomes worldwide.

🌐 Learn more: https://jobs.iqvia.com


Job Overview

As Associate/Director of Biostatistics, you will lead cross-functional collaboration to ensure high-quality statistical planning, analysis, and reporting that supports pharmaceutical development and regulatory submissions, specifically in rare diseases. You will serve as a scientific resource, lead major projects, and maintain regulatory compliance and scientific integrity in statistical applications.


Key Responsibilities

Leadership

  • Act as a biostatistical consultant within the department and across other Biostatistics teams

  • Represent sponsors in regulatory agency meetings and possibly serve on Data and Safety Monitoring Committees

  • Lead major projects as the high-level biostatistician, including protocol development, analysis plan preparation, and writing clinical/statistical reports

  • Lead operational aspects of studies

  • Initiate and review statistical methodology development and validation procedures

  • Consult on operational, statistical, and therapeutic area issues

Knowledge Sharing

  • Stay current with developments in biostatistics, clinical trial methodology, and regulatory requirements

  • Serve as a subject matter expert (SME)

Risk Management

  • Identify and mitigate risks to project delivery and quality

  • Anticipate and resolve issues before escalation

Lock and Unblinding Process

  • Lead the database lock and unblinding process for statistical teams

  • Participate in drafting and quality control of randomization specifications and schedules

Statistical Expertise

  • Provide expert review of statistical deliverables (protocol sections, analysis plans, tables/listings/figures, integrated reports)

  • Review data management deliverables (database design, CRF design, validation checks)

  • Review ADaM Reviewer’s Guide (ADRG) and metadata

  • Conduct senior biostatistical reviews (SBR)

  • Perform and quality control sample size calculations for complex studies


Requirements

  • MS or PhD in Biostatistics or related field

  • Minimum 8 years relevant experience in the life sciences industry

  • Expertise in complex statistical methods applicable to Phase 2 and 3 clinical trials

  • Proven experience leading statistical efforts in regulatory submissions, including dataset preparation, eCTD support, regulatory meetings, and query responses

  • In-depth knowledge of clinical research regulatory requirements, Good Clinical Practice (GCP), and ICH guidelines

  • Strong proficiency with SAS and R programming languages

  • Excellent knowledge of CDISC data standards

  • Exceptional communication and collaboration skills

  • Independent and proactive problem-solving ability

  • Experience in rare disease and immunology highly preferred


Compensation & Benefits

💰 Base Pay Range (Annualized): $161,100 – $299,100
Actual pay may vary based on qualifications, location, and schedule.
Additional compensation may include bonuses, incentive plans, and comprehensive health and welfare benefits.


Work Environment

🏠 Remote / Home-based (U.S. or Canada) — East Coast preferred


Equal Employment Opportunity

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

🔗 EEO Policy


How to Apply

🔗 Apply Now