Principal Biostatistician FSP - Late Phase Oncology

Job Description

Who Are You?

An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead late phase Oncology 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.

Responsibilities

As a Principal Biostatistician, your responsibilities will include:

• Provide statistical leadership and statistical expertise into clinical development plans, concept sheets and protocols for clinical development projects, represent Cytel and the statistical team on the Product Development Teams of sponsors.
• Needs to be experienced in Oncology (preferred in hematology and late phase) and expected to have prior experience of working on a registrational study, playing an independent statistician role, sitting in study team meetings and discussing with the team on statistical analysis plan, design of outputs, addressing health authority questions
• Lead statistical teams on clinical development projects, ensuring alignment of objectives and delivery of statistical output on time and meeting project requirements, coordinating all statistical aspects across clinical trials of each assigned project.
• Provide statistical input into study protocols, Case Report Forms, and data management plans, write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.
• Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities.
• Needs familiarity with ADAM and SDTM and can do hands-on work (e.g., derive outputs or summary statistics) to address team’s questions quickly
• When in the Lead Biostatistician role for a project: manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes.
• Generate the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies and techniques appropriate to each project, and contribute internally and externally to the development and visibility of the company and of the Clinical Services department through her/his expertise and customer orientation.
• Contribute to the development of sourcing strategy for projects.
• Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.
  
  

Qualifications

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:

Qualifications And Experience

• Minimum Education: Ph.D. or MS in Statistics, Biostatistics or related discipline.
• Minimum Work Requirements:
• At least 6 years of experience as biostatistician in the Pharmaceutical/Biotechnology industry in clinical development.
• At least 3 years of experience as a Lead Biostatistician for clinical development projects.
• Knowledge of relevant international regulatory guidelines applicable to clinical development, and some experience of regulatory interactions and data e-submission to FDA.
• Fluent in English (French or German is a plus).
• Working SAS & CDISC knowledge.
• Experience in R is a plus.
  
  

Skills

• Works effectively in international teams, effectively operates within a matrix organization and with multi-disciplinary groups.
• Understands and anticipates customer needs and responds to their inquiries.
• Verbal and written communication is effective with multi-disciplinary groups.
• Work is well-organized, of high-quality, meeting timelines. Able to balance concurrent tasks and responsibilities.
• Excellent time management.
• Brings creative ideas and makes suggestions for optimization.
• Exhibits leadership for the biostatistics team working on the same clinical development teams.
• Exhibits the ability to mentor and develop statistical colleagues.