Biostatistician 1

Company: Cytel Software Corporation
Location: Fort Collins
Posted on: June 18, 2022

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 a Biostatistician or Senior Biostatistician you will support Cytel and a client of our Functional Service Provider (FSP) division's Full Development activities. You should have experience with clinical trials and a solid background in statistics. Contributions may include:

• Participation in clinical trial activities (mostly phase 2-4) as part of a cross-function team
• Lead or support clinical trial activities from a statistician perspective
• 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
• Contribute to project level activities (e.g. pooling specification, ISS/E planning, submission and Health Authority Questions) as appropriate
• Support reporting of clinical trial activities and communication with clinical team members.
• Review and give input to other documents (e.g. clinical study protocol, clinical study report) as appropriate
• Contribute to other activities, e.g. adhoc requests, publication related analyses etc. as appropriate.What we are looking for:
  • Masters degree in statistics or a related discipline.
  • At least 3-5 years' experience supporting clinical trials and projects as a statistician in a pharmaceutical company or CRO
  • Experience with regulatory submission activities, clinical summaries etc. is a plus
  • Solid experience writing Statistical Analysis Plans and overseeing TFL production from a statistical perspective
  • Strong SAS skills
    • Familiarity with CDISC specifications, in particular ADaM and reporting
    • Good operational and communication skills
    • Constructive collaborative attitude
    • Results-oriented with good ethicsWhats 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 Cytels 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 industryCytel 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 Cytels 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.Required
        Preferred

        Job Industries

        • Customer Service

Keywords: Cytel Software Corporation, Fort Collins , Biostatistician 1, Other , Fort Collins, Colorado