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Principal Biostatistician Oncology (FSP -Permanent Homebased)
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Principal Biostatistician Oncology (FSP -Permanent Homebased)
role at
Nanosep AB We are seeking an experienced and proactive
Principal
Biostatistician
to join our FSP team, supporting a global pharmaceutical client. This is a
permanent, home-based
position offering the opportunity to work on
late-phase global oncology trials
, with a focus on
hematology
and
regulatory submissions
.
Key Responsibilities
Serve as the lead statistician on global late-phase registration trials, particularly in oncology (hematology preferred). Independently contribute to study design, statistical analysis plans (SAPs), and regulatory submission strategies. Participate in study team meetings, providing statistical guidance and collaborating with cross-functional teams. Address health authority questions and support responses with appropriate statistical analyses and documentation. Perform hands-on statistical programming to derive outputs and summary statistics using ADaM and SDTM datasets. Ensure timely and accurate delivery of statistical deliverables in compliance with regulatory standards
Required Qualifications
Advanced degree (Masters or PhD) in Biostatistics, Statistics, or a related field. 5+ years of experience in clinical trials, with a strong focus on oncology (hematology and late-phase preferred). Proven experience working on registrational studies and regulatory submissions. Strong knowledge of CDISC standards, particularly ADaM and SDTM. Proficiency in SAS programming and ability to perform hands-on statistical analyses. Excellent communication skills and ability to work independently in a global, cross-functional environment.
Preferred Experience
Prior involvement in FDA/EMA submissions. Experience addressing regulatory agency queries. Familiarity with real-world evidence and observational studies is a plus.
Why Join Us?
Work on high-impact global studies with a focus on improving cancer treatment outcomes. Be part of a collaborative and innovative team environment. Enjoy the flexibility of remote work with a permanent contract. Gain exposure to regulatory strategy and cutting-edge oncology research .
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 a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
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