Senior Biostatistician – Oncology (FSP -Permanent Homebased)

IQVIA; Roma; In loco; EUR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

IQVIA is looking for an experienced Senior Biostatistician to join its FSP team. This permanent, home-based role involves leading statistical efforts on late-phase global oncology trials, particularly focusing on hematology and regulatory submissions. Join a collaborative environment and contribute to significant cancer treatment developments while enjoying the flexibility of remote work.

Servizi

Flexibility of remote work

Collaborative team environment

Involvement in cutting-edge oncology research

Competenze

• 5+ years of experience in clinical trials with a focus on oncology.
• Proficiency in CDISC standards including ADaM and SDTM.
• Proven experience in regulatory submissions and statistical analyses.

Mansioni

• Lead statistician for global late-phase oncology trials.
• Develop statistical analysis plans and regulatory submission strategies.
• Perform statistical programming to derive outputs and summary statistics.

Conoscenze

Statistical programming

Communication

Oncology expertise

CDISC standards

Independent work

Formazione

Master’s or PhD in Biostatistics

Strumenti

SAS

Descrizione del lavoro

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Job Reference:

db174f4fbb08

Job Views:

3

Posted:

17.07.2025

Expiry Date:

31.08.2025

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Job Description:

We are seeking an experienced and proactive Senior 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 (Master’s 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