Principal Biostatistician – HTA Statistics (m/w/d)

### **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.* 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 atWe 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**.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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