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Principal Biostatistician (Oncology) - FSP

IMSH Tech Sol Egypt L.L.C (EG71)
šŸ‡¬šŸ‡§ United Kingdom
On-site
Staff / Principal
2 weeks ago
  • CDISC

Not enough detail in this posting to match

As aPrincipal Biostatistician, you will provide strategic statistical leadership forOncology clinical trials, with a particular focus onhematological malignancies includingmultiple 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 ofSDTM datasets and associated deliverables, ensuring compliance withCDISC 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

āœ” Advanced experience as aPrincipal Biostatistician within a Pharmaceutical, Biotechnology, or CRO environment
āœ” Strong experience withinOncology clinical development
āœ” Demonstrated expertise inhematological malignancies, includingmultiple myeloma, leukemia, and/or lymphoma
āœ” Strong knowledge and practical application ofCDISC standards, includingSDTM
āœ” Experience performing or overseeingQC of SDTM datasets and related outputs
āœ” Proven ability to work effectively within cross-functional teams and influence key stakeholders
āœ” Excellent verbal and written communication skills
āœ” Strong understanding of statistical principles and clinical trial methodology

Preferred Qualifications

āœ” Experience serving asLead Study Statistician within a cross-functional clinical development team
āœ” Knowledge and experience inclinical trial statistical design and study planning
āœ” Experience supporting regulatory submissions and interactions with health authorities
āœ” 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 athttps://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.

Principal Biostatistician (Oncology) - FSP Ā· IMSH Tech Sol Egypt L.L.C (EG71)

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