Leads statistical activities for Phase II–III oncology trials from protocol design through results reporting. Provides clinical development, endpoint analysis, SAP, regulatory, safety, and submission support; oversees programming and CRO work; conducts analyses using SAS and R; collaborates with cross-functional teams, sponsors, and health authorities; and mentors junior statisticians across multiple concurrent studies.
Who Are You?
An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead one Phase I-IV clinical studies across your region. You are excited and enthusiastic, motivate your teams to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.
Sponsor-dedicated:
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
Position Overview:
Our Principal Biostatisticians provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. You will formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use.
As a Principal Biostatistician, your responsibilities will include:
- Lead statistical activities for assigned Clinical Trials (Phases 2 to 3) independently from protocol design to reporting of results.
- Represent Statistics function on cross-functional trial (and possibly indication / project) teams and collaborate effectively with all cross-functional stakeholders.
- Oversight of internal programming activities and/or CRO contributions on assigned clinical trials and other activities.
- Contribute to or lead other activities from a statistical perspective as appropriate, including but not limited to Safety Reporting, ISS/ISE, addressing questions from Health Authorities, Publications.
- Use SAS and/or R for purposes like QC of datasets and deliverables, inferential statistical analyses, modelling/simulation, exploratory analyses etc.
- Contribute to and participate in other initiatives at Cytel or sponsor side as appropriate.
- Oversight of more junior Statisticians as required.
Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
Required Qualifications
- PhD or Master's degree in Statistics, Biostatistics, Mathematics, or a related quantitative discipline.
- Significant biostatistics experience within the pharmaceutical, biotechnology, or CRO industry.
- Direct hands-on experience supporting at least one Phase III Oncology clinical trial.
- Strong understanding of oncology clinical development and endpoint analysis.
- Demonstrated experience with:
- Overall Survival (OS)
- Progression-Free Survival (PFS)
- Objective Response Rate (ORR)
- Duration of Response (DoR)
- Time-to-event analyses
- Censoring methodologies
- Proven expertise with Kaplan-Meier analyses, Cox Proportional Hazards models, and stratified log-rank tests.
- Experience authoring and reviewing Statistical Analysis Plans (SAPs).
- Strong collaboration experience with Statistical Programming teams, including ADaM specifications and TFL development.
- Advanced proficiency in SAS for output review, validation, and independent analyses.
- Ability to manage multiple concurrent studies and competing priorities.
- Excellent communication and stakeholder management skills.
- Demonstrated ability to work independently with minimal supervision and rapidly integrate into established study teams.
- Experience supporting FDA, EMA, and global regulatory submissions.
- Prior involvement with eCTD or electronic submission packages.
- Experience supporting IDMC/DMC meetings and interim analyses.
- Working knowledge of R programming.
- Experience in sponsor-dedicated or embedded partnership models.
- Exposure to late-phase oncology registration trials and submission-enabling programs.
The successful candidate will be a highly independent statistical leader who can quickly onboard into a complex oncology portfolio, confidently manage multiple studies simultaneously, and deliver high-quality statistical guidance and regulatory-ready outputs while partnering closely with sponsor teams. This individual combines deep oncology expertise, strong technical skills, and exceptional cross-functional collaboration to drive successful clinical development outcomes.
Similar Jobs
.png)
Artificial Intelligence • Cloud • Payments • Software • Business Intelligence • Generative AI • Automation
Sell connectivity, data solutions, and AI-powered risk digitization software to insurance carriers and MGA clients across Canada. Responsibilities include developing strategic account plans, acquiring new logos, expanding existing accounts, managing executive relationships, negotiating renewals, forecasting sales, gathering market feedback, and meeting or exceeding quotas. The role uses a consultative solution-selling methodology and involves virtual, telephone, onsite, and industry-event engagements.
Top Skills:
Ai-Powered Risk Digitization PlatformsCrm SystemsExcelMicrosoft OutlookMicrosoft PowerpointMicrosoft WordSalesforceSlack
.png){kind=logo}
AdTech • Cloud • Digital Media • Information Technology • News + Entertainment • App development
Leads the visual direction, quality, consistency, and scalability of character assets for a large-scale interactive entertainment project. Manages Character Art Leads and review artists, establishes standards, reviews assets, mentors teams, and collaborates with animation, design, technical art, and lighting. The role also coordinates internal and external partners, addresses production risks, and ensures character systems perform across platforms and scalable real-time pipelines.
Top Skills:
MetahumanUnreal Engine 5
AdTech • Cloud • Digital Media • Information Technology • News + Entertainment • App development
Defines facial art standards and solves complex character challenges for an interactive entertainment project. Leads facial modeling, scanning, blendshape, rigging, and real-time character workflows while collaborating with animation and technical art teams. Advances pipelines, tools, benchmarks, and best practices; validates facial assets for visual quality, expressiveness, realism, and technical consistency. Provides high-level guidance and drives innovation across modular character production.
Top Skills:
3D ScanningBlendshapesMetahumanPerformance CaptureReal-Time Character PipelinesUnreal Engine
What you need to know about the Edinburgh Tech Scene
From traditional pubs and centuries-old universities to sleek shopping malls and glass-paneled office buildings, Edinburgh's architecture reflects its unique blend of history and modernity. But the fusion of past and future isn't just visible in its buildings; it's also shaping the city's economy. Named the United Kingdom's leading technology ecosystem outside of London, Edinburgh plays host to major global companies like Apple and Adobe, as well as a growing number of innovative startups in fields like cybersecurity, finance and healthcare.
