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Cytel provides unrivalled biostatistics and operations research to improve drug development success rates, crucial for human welfare. Focused on using innovative applications of statistical science and adaptive clinical trial design, Cytel is at the cutting edge of technology and human ingenuity, driving healthcare forward.
We are hiring a remote Senior Biostatistician to lead and/or support clinical trials for a major pharma company. This position reports to the Sr. Director, Biostatistics in the FSP Services business unit in Cytel.
This FSP statistician will provide statistical support to all non-clinical and pre-clinical studies in the Discovery group. The incumbent will be responsible for assisting the preclinical group in the design, analysis, and interpretation of immunogenicity and animal challenge studies in the Zika program. The statistician will also support the serology and analytical groups in the qualification and validation of assays critical in the development of novel vaccines. The incumbent will be expected to display some flexibility and, when pertinent, be able to carry some additional projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Provides statistical support to all non-clinical projects and supports appropriate statistical needs to the Discovery group.
- Involves at early stage in study design
- Provides statistical support to all projects and supports appropriate statistical needs to the Discovery group.
- Develops statistical methodology to support pre-clinical and non-clinical studies including bioassays, assays qualification and validation.
- Provides statistical support for transfer, concordance, and optimization studies in the laboratories
- Assists the Animal Studies department in the design and analysis of immunogenicity and animal challenge studies.
- Presents statistical findings/issues to the Project Team and other internal meetings when required on an ad-hoc basis, as defined by the Project Team and the Head of the department.
QUALIFICATIONS AND REQUIREMENTS:
- Master's Degree in Statistics, Biostatistics, or related discipline.
- 3+ years' experience with drug development statistical analysis with a biotechnology or pharmaceutical company.
- Excellent oral and written communications skills.
- In depth knowledge of statistical and modeling software including R, Python, and SAS.
- Knowledge of designs of experiments (DOE) is a plus
- Knowledge of mixed effects modeling, variance component analysis is a plus
- Knowledge of Machine learning algorithms is a plus
- Knowledge of statistical methods for vaccine development is a plus
- Familiarity with regulatory guidance pertinent to assay development.
- Excellent oral and written communication skills.
- Proven ability to coordinate multi-disciplinary project teams.
- Strong collaborative skills and ability to work with a cross-functional team.