Principal Biostatistician - Medical Affairs

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, because 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. In this role you will join our FSP department and will work for our clients, a growing biotech.

Ihre Aufgaben

As Medical Affairs Biostatistician, you are responsible for statistical activities in support of Medical Affairs, including contributing to post approval study designs, study protocol and analysis plan development, reviewing and interpreting the analysis of study data, and conducting ad hoc and exploratory analyses.

You will contribute by:

• Collaborates with Medical Affairs (Medical Research and Value, Evidence & Strategy), Medical Communications and Publications, Epidemiology and Regulatory to design post approval studies.

• Writes the statistical sections of study protocols, while consulting with internal and external experts.

• Contributes to or prepares statistical analysis plans.

• Collaborates with Data Management and Medical Research on design of eCRFs.

• Provides statistical guidance on conduct of ongoing studies.

• Accountable for the collaboration with Statistical Programming to implement statistical analysis of all clinical trial, registry, observational and non-interventional data supporting Medical Affairs needs

• Contributes observational study reports and regulatory documents, e.g., DSURs, briefing documents, etc.

• Contributes to scientific articles, summarizing data collected in studies.

• Participates in other activities and meetings to support Biostatistics and the Medical Affairs team as needed.

• Reviews abstracts, manuscripts for publications and presentations.,

• 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 in Senior and Leadership positions 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

Ihr Profil

• PhD in Biostatistics, Statistics, or equivalent with at least 3 years pharmaceutical biostatistics experience; or MS with at least 5 years' relevant experience.

• Excellent written and oral communication and presentation skills.

• Extensive experience programming in SAS.

• Extensive experiences working on data analysis with clinical studies database

• Experience working on post-approval observational and clinical studies.

• Understanding of ICH GCP as well as general knowledge of industry practices and standards.

• Experiences in R programming language and other statistical software.

• Experience with CDISC, including SDTM, ADaM, CDASH.