Principal Biostatistician - Safety

Company: Cytel Software Corporation
Location: Augusta
Posted on: August 5, 2022

Job Description:

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 supporting clinical trial design and analysis. As an experienced pharmaceutical statistician you will support Cytel and a client of our Functional Service Provider (FSP) division. You will be supporting safety activities for our client's projects, including but not limited to data pooling, Integrated Summary of Safety (ISS), Data Safety Update Reports (DSUR), Data Monitoring Committees (DMC/DSMB) etc. You may support safety-related standardizationor innovation activities for our client. Contributions may include:

• Work in close collaboration with our clients' safety and project teams, understand their needs and help develop appropriate safety pooling and reporting strategies
• Take the lead or contribute to specifying pooled ADaM datasets, integrated analysis plans for ISS, DSUR, Investigator's Brochures, Data Monitoring Committees and other safety related activities
• Oversee and contribute to programming activities, validation and statistical QC.
• Organize and plan team work for safety related statistical/programming requirements as appropriate.
• Participate in safety standardization or innovative safety evaluation initiatives.
• Support trial level safety activities as required.
• Contribute to answering health authority request, advisory activities, initiatives, publication, presentation, integration of new team members etc. as required. What we are looking for:
  • At least Master s degree in statistics or a closely related discipline.
  • 7+ years of experience supporting clinical trials and projects in the Pharmaceutical or Biotechnology industry
  • Experience with safety pooling, ISS and other project-level safety activities is required, ideally in a lead role from a sponsor's perspective.
  • Knowledge of current trends and technologies in safety evaluation (including safety signal detection, visualization etc) strongly desired
  • Strong knowledge of ADaM and safety reporting standards and regulatory requirements
  • Ability to lead and plan team activities
  • Strong communicator and teamworker
  • Strong skills using SAS
  • Good work ethics, results oriented 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 working with safety specialist as well as with several cross-functional project and trial teams
    • 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.

Keywords: Cytel Software Corporation, Augusta , Principal Biostatistician - Safety, Other , Augusta, Georgia