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 Functional Service Provider (FSP) department offers statistical programmers, biostatisticians and clinical data specialists amazing opportunities to work on client projects.
As a Principal Biostatistician you will support Cytel and a client of our Functional Service Provider (FSP) division's activities. You should have experience with clinical trials and projects and a solid background in statistics.
Contributions may include:
- Participation and leadership in trial and project activities (phases I-IV) from the statistical perspective as part of a cross-functional team
- Lead and support clinical trial activities from a statistician perspective, from protocol development to reporting
- Lead and support project level activities, including development planning and submission related activities (ISS/E, health authority interactions etc.)
- Develop, contribute to and review Statistical Analysis Plans (SAPs) and provide specifications for the programming activities
- Oversee programming activities (mostly using SAS), including hands-on programming contributions and QC of programmers' (and other statisticians') deliverables
- Oversee or QC deliverables from other providers as required.
- Support reporting of clinical trial and pooled data results and communication with clinical team members.
- Support other activitities on the assigned project where required (e.g. publication activities, safety reporting, adhoc requests)
- What we are looking for:
- At least Master’s degree in statistics or a related discipline.
- 10+ years' experience supporting clinical trials and projects as a statistician, ideally in a pharmaceutical company or in an FSP model at a CRO
- Experience with regulatory submission activities, clinical summaries etc. is highly desired
- Strong technical/methodological skill
- Strong experience writing Statistical Analysis Plans, Project level analysis planning, and overseeing TFL production from a statistical perspective
- Strong SAS and potentially R skills
- Familiarity with CDISC specifications, in particular ADaM and reporting
- Strong strategic, operational and communication skills
- Constructive collaborative attitude
- 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
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.