IQVIA · 4 days ago
Associate/Director of Biostatistics, Rare Disease, FSP
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
$161K/yr - $299K/yr
8+ years expIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. As an Associate Director, you will drive quality statistical planning, analysis, and reporting in support of pharmaceutical development and regulatory submissions while ensuring scientific integrity and compliance with statistical methodology in clinical trials.
AnalyticsHealth CareLife Science
Responsibilities
Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the company
Represent sponsors at meetings with regulatory agencies or other regulatory meetings, may participate as a member of a Data and Safety Monitoring Committee
Participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication
Participate as high-level lead biostatistician on major projects, including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, integrated summaries, and/or NDA sections
Lead studies at an operational level
Provide expert review and initiate methodology development work with regards to statistical standards and validation procedures
Consult on operational/statistical/therapeutic area topics
Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact analyses
Perform as subject matter expert (SME)
Identify risks to project delivery and/or quality, lead in a way to minimize risks
Anticipate risks to avert the need for study-level escalations, support lead in implementing risk mitigation actions
Lead the database lock and unblinding process for the statistical team
Participate on the biostatistics randomization team (draft randomization specifications and/or perform quality control (QC) review of randomization schedules)
Provide expert statistical input into the review of statistical deliverables (i.e., statistical section of a protocol, statistical analysis plans, table shells, programming and table specifications, data review, tables, listings, figures, and statistical sections for complex and/or integrated reports)
Provide expert input into data management deliverables (i.e., database design, CRF design, validation checks, and critical data)
Provide expert review of ADaM reviewers guide (ADRG) and metadata
Perform senior biostatistical review (SBR)
Produce or perform quality control review of sample size calculations for complex studies
Qualification
Required
MS or PhD degree in Biostatistics or a related field and 8+ years' relevant experience within the life-science industry
Expert in a broad range of complex statistical methods that apply to Phase 2-3 clinical trials
Expert in strategically collaborating with clinical and drug development experts
Experience in serving as statistical lead for regulatory submissions, including preparation of submission datasets, eCTD support, meeting with regulatory teams, and responding to regulatory queries
In-depth knowledge of applicable clinical research regulatory requirements, Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) guidelines
Strong working knowledge of SAS and R
Excellent knowledge of CDISC Data Standards
Superb communication and collaboration skills
Independent and proactive problem-solving skills
Preferred
Rare disease and immunology experience is greatly preferred
Benefits
Incentive plans
Bonuses
Health and welfare
Company
IQVIA
IQVIA provides analytics, compliance, and management solutions to the life sciences industry.
10001+ employees
H1B Sponsorship
IQVIA has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (294)
2023 (261)
2022 (229)
2021 (208)
2020 (180)
Funding
Current Stage
Public CompanyTotal Funding
$3.5B2025-06-02Post Ipo Debt· $2B
2023-11-14Post Ipo Debt· $500M
2023-05-18Post Ipo Debt· $1B
Leadership Team
Chris Colapietro
Vice President, Customer Engagement
Jonathan Morris
VP & GM US Healthcare
Recent News
Sabin Vaccine Institute
2025-12-04
Company data provided by crunchbase