Principal Biostatistician (Early Drug Development)

Full Job Description

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services.  At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.

Cytel's Flexible Solutions Program (FSP) offers statistical programmers, biostatisticians and clinical data specialists amazing opportunities to work on client projects supporting clinical trial design and analysis.

As an experienced Early Development Biostatistician  you will support Cytel and a client of our Functional Service Provider (FSP) division Phase 1 and Phase 2a activities (non-oncology Early Development).  You should possess strong cross-functional communication, strategic thinking and operational leadership skills from a statistical perspective as well as a strong technical statistical knowledge.

Contributions may include:

• Participation and statistical leadership in Early Development (phase 1 and 2a) projects
• Strategic statistical input to clients' project teams in planning and conduct of Early Phase projects
• Oversight and leadership on statistical and programming activities for trials and projects in early phase, including hands-on and QC activities using client internal resources and/or external providers
• Statistical input into design of PK, proof-of-concept and other types of early phase trials; including modelling/simulation activities
• Participation in Health Authority related interactions and in preparation of New Drug Application (NDA) submissions (from an ED perspective) and other relevant regulatory documents
• Development and review of Statistical Analysis Plans (SAP), programming specifications etc. as appropriate; review of and input to other study or project related documents as appropriate

What we are looking for:

• Master’s degree in statistics or a related discipline. PhD desirable.
• 8+ years supporting clinical trials and project in the Pharmaceutical or Biotechnology industry, with considerable focus on Phase 1 and 2a activities from the sponsor's perspective 

• Experience and skills in leading statistical activities, instructing and guiding team efforts
• Solid skills using SAS and other relevant tools
• Advanced technical statistical knowledge is highly desired, including Bayesian modelling and simulation
• Experience with Summary of Clinical Pharmacology and other regulatory related activities, guidelines and requirements strongly desired
• Strategic thinking combined with a constructive collaborative attitude
• Effective communicator: able to explain methodology and consequences of decisions in lay terms.
• Great operational skills in leading team efforts from a statistical perspective
• Results-oriented with good ethics

What’s in it for you:

• You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development
• You will be part of an exciting new chapter in Cytel’s history with high growth and opportunities to progress within the company
• Work in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementation
• Work with and leverage the best and brightest minds in the industry

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Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.