The Senior Biostatistician will lead statistical efforts on global late-phase oncology trials, focusing on study design, analysis plans, and regulatory submissions while ensuring compliance and accuracy in deliverables.
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
- 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.
- 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 at https://jobs.iqvia.com
Top Skills
Adam
Cdisc Standards
SAS
Sdtm
Similar Jobs
Financial Services
As a Lead Software Engineer, you'll design and develop software solutions, lead technical evaluations, and enhance operational stability in an agile environment, focusing on financial services.
Top Skills:
.NetAngularArtificial IntelligenceC#CloudHazelcastKafkaMachine LearningMobileMulti-Threaded ApplicationsRabbitMQReactRedisTypescript
Financial Services
The Senior Lead Software Engineer will develop secure code, drive product design decisions, and provide technical guidance within an agile team, focusing on network automation and cloud technologies.
Top Skills:
AngularAWSBashGitGrafanaInfluxdbJavaJavaScriptNoSQLPythonReactSplunkSQL
Big Data • Food • Hardware • Machine Learning • Retail • Automation • Manufacturing
Lead the creation of a Consumer Data Ecosystem solution, focusing on technical development, data integration, and compliance with data privacy standards while collaborating with cross-functional teams.
Top Skills:
Ai PlatformAPIsBigQueryDataflowETLGoogle Cloud PlatformWeb Services
What you need to know about the London Tech Scene
London isn't just a hub for established businesses; it's also a nursery for innovation. Boasting one of the most recognized fintech ecosystems in Europe, attracting billions in investments each year, London's success has made it a go-to destination for startups looking to make their mark. Top U.K. companies like Hoptin, Moneybox and Marshmallow have already made the city their base — yet fintech is just the beginning. From healthtech to renewable energy to cybersecurity and beyond, the city's startups are breaking new ground across a range of industries.
