Principal Biostatistician (Oncology) - FSP

Posted 3 Days Ago
Be an Early Applicant
18 Locations
In-Office or Remote
Expert/Leader
Healthtech
The Role
Lead statistical strategy and execution for oncology clinical trials (focused on hematologic malignancies). Provide principal-level biostatistics leadership, QC SDTM datasets per CDISC, collaborate with programming, data management, operations and regulatory teams, support study design and regulatory interactions, and communicate results to stakeholders.
Summary Generated by Built In

As a Principal Biostatistician, you will provide strategic statistical leadership for Oncology clinical trials, with a particular focus on hematological malignancies including multiple myeloma, leukemia, and lymphoma. You will work closely with cross-functional teams to deliver high-quality statistical support across the clinical development lifecycle, ensuring compliance with regulatory and industry standards.

Key Responsibilities

• Provide Principal-level Biostatistics leadership for Oncology clinical development programs and studies
• Lead and contribute to statistical activities across clinical trials, acting as the primary statistical representative on assigned studies
• Review and provide quality control oversight of SDTM datasets and associated deliverables, ensuring compliance with CDISC standards
• Collaborate closely with Statistical Programming, Data Management, Clinical Operations, and Regulatory teams to ensure accurate and timely delivery of statistical outputs
• Support the interpretation and communication of study results to cross-functional stakeholders
• Ensure all statistical deliverables meet quality, regulatory, and timeline expectations
• Effectively communicate statistical concepts, analyses, and recommendations to both technical and non-technical audiences
• Contribute to study design discussions, protocol development, and statistical methodology as required

Candidate Requirements

✔ Advanced experience as a Principal Biostatistician within a Pharmaceutical, Biotechnology, or CRO environment
✔ Strong experience within Oncology clinical development
✔ Demonstrated expertise in hematological malignancies, including multiple myeloma, leukemia, and/or lymphoma
✔ Strong knowledge and practical application of CDISC standards, including SDTM
✔ Experience performing or overseeing QC of SDTM datasets and related outputs
✔ Proven ability to work effectively within cross-functional teams and influence key stakeholders
✔ Excellent verbal and written communication skills
✔ Strong understanding of statistical principles and clinical trial methodology

Preferred Qualifications

✔ Experience serving as Lead Study Statistician within a cross-functional clinical development team
✔ Knowledge and experience in clinical trial statistical design and study planning
✔ Experience supporting regulatory submissions and interactions with health authorities
✔ Familiarity with advanced statistical programming tools and industry-standard processes

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

Skills Required

  • Advanced experience as a Principal Biostatistician within a Pharmaceutical, Biotechnology, or CRO environment
  • Strong experience within Oncology clinical development
  • Demonstrated expertise in hematological malignancies (multiple myeloma, leukemia, and/or lymphoma)
  • Strong knowledge and practical application of CDISC standards
  • Practical knowledge of SDTM
  • Experience performing or overseeing QC of SDTM datasets and related outputs
  • Proven ability to work effectively within cross-functional teams and influence key stakeholders
  • Excellent verbal and written communication skills
  • Strong understanding of statistical principles and clinical trial methodology
  • Experience serving as Lead Study Statistician within a cross-functional clinical development team
  • Knowledge and experience in clinical trial statistical design and study planning
  • Experience supporting regulatory submissions and interactions with health authorities
  • Familiarity with advanced statistical programming tools and industry-standard processes

IQVIA Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about IQVIA and has not been reviewed or approved by IQVIA.

  • Healthcare Strength Healthcare coverage is positioned as comprehensive, spanning medical/dental/vision plus programs like telemedicine, EAP resources, and additional insurance options. Feedback suggests the health offering is a meaningful part of the overall rewards package, though details can vary by location and plan design.
  • Retirement Support Retirement benefits include an employer match structure that supports employee contributions through a defined formula. This adds steady long-term value to total rewards beyond base salary.
  • Leave & Time Off Breadth Time off offerings include vacation/paid time off, holidays, and flexibility themes, with some roles described as having discretionary or unlimited time-off models. This can make the package feel more attractive even when cash compensation is viewed as only mid-range.

IQVIA Insights

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The Company
HQ: Durham, NC
61,500 Employees
Year Founded: 2016

What We Do

IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 70,000 employees, IQVIA conducts operations in more than 100 countries. To learn more, visit www.iqvia.com.

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