Principal Biostatistician FSP - Late Phase Oncology

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 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.

• 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.

Success Profile 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.

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