Principal Medical Affairs Biostatistician NEW!
JOB DESCRIPTION
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.
RESPONSIBILITIES
As a Principal Biostatistician, Medical Affairs, your responsibilities include:
- 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.
QUALIFICATIONS
What we’re looking for:
- 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.
ABOUT US
Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty years, Cytel’s scientific rigor and operational excellence have helped biotech and pharmaceutical companies navigate uncertainty, prove value and unlock the full potential of their data.
Come be a part of a team where talent, experience and scientific rigor come together to advance the state of clinical development. As the industry's largest provider of statistical software and advanced analytics, Cytel is home to some of the most innovative, collaborative and rigorous biostatistics, statistical programming and data management talent.Cytel careers offer meaningful work and stimulating challenges within a welcoming and diverse global culture.
Whether your specialty is biostatistics, statistical programming, adaptive clinical trial design, clinical data management, Bayesian statistics, real-world evidence, artificial intelligence, health economics, or a corporate function, you will be growing an exciting career while contributing to advancing the future of human health at Cytel.Search our open jobs or get in touch today to find your fit!