Principal Biostatistician – Oncology (Hematological Malignancies)
IQVIA · Ig
Opis delovnega mesta
About the role
The Principal Biostatistician will provide strategic statistical leadership for oncology clinical trials, focusing on hematological malignancies such as multiple myeloma, leukemia, and lymphoma. Working closely with cross‑functional teams, you will ensure high‑quality statistical support throughout the clinical development lifecycle and maintain compliance with regulatory and industry standards.
Key responsibilities
- Lead and represent statistical activities on oncology programs, acting as the primary statistical contact for assigned studies.
- Review and QC SDTM datasets and related deliverables to ensure CDISC compliance.
- Collaborate with Statistical Programming, Data Management, Clinical Operations, and Regulatory teams to deliver accurate statistical outputs on schedule.
- Support interpretation and communication of study results to both technical and non‑technical stakeholders.
- Contribute to study design, protocol development, and methodological discussions.
Required profile
- Advanced experience as a Principal Biostatistician in a pharmaceutical, biotech, or CRO environment.
- Strong background in oncology clinical development, especially hematological malignancies.
- Proven ability to work within cross‑functional teams and influence key stakeholders.
- Excellent verbal and written communication skills.
Required skills
- Expertise with CDISC SDTM standards.
- Statistical programming proficiency.
- Experience performing or overseeing QC of SDTM datasets.
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Ig
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