Principal Biostatistician FSP

Who Are You?    An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support 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. You will be part of Biometrics Team that is an innovation-driven and execution-minded group of drug development professionals responsible for supporting client's innovative science through novel trial design, data collection, integration, analysis, and enabling data-driven decision making.
  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:

• Provide expert guidance on design options, outcome measures, endpoint assessments, and sample size/power calculations during protocol development. Author statistical sections of protocols, clinical study reports (CSRs), regulatory documents, and statistical analysis plans (SAP) for CSRs and integrated summaries
• Conduct advanced statistical analysis and ensure robust and accurate data analysis through extensive knowledge in biostatistics
• Facilitate execution and delivery collaboration with cross-functional teams to achieve project objectives
• Lead and be accountable for study level delivery strategies being implemented with effective risk identification and mitigation
• Manage biometrics vendors and contracted personnel, ensuring alignment with statistical methodologies and project objectives

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: 

• PhD or MSc in Biostatistics, Statistics, with 5+ years of biostatistics experience in a pharmaceutical or biotechnology company
• Advanced expertise in statistical methods in innovative trial design and analysis
• Strong ability to manage competing priorities and deliver high-quality work under tight timelines
• Strong proficiency in programming, experience in SAS and preferably in R/R Shiny and Python
• Understanding of GCP, ICH, CDISC, and other regulatory guidance and standards. Excellent project management skills, including the ability to oversee competing priorities and deliver high-quality work while ensuring adherence to data standards such as CDISC, SDTM, and ADaM, and relevant regulatory requirements
• Experience in oncology and rare disease clinical trials.