Company: Cytel Software Corporation
Posted on: August 5, 2022
Join us in playing an important part in helping our clients
drive healthcare forward and ultimately improve human health
outcomes! 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. OBJECTIVE: 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
- 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.
- None QUALIFICATIONS AND REQUIREMENTS:
- Master s Degree in Statistics, Biostatistics, or related
- 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
- Familiarity with regulatory guidance pertinent to assay
- Excellent oral and written communication skills.
- Proven ability to coordinate multi-disciplinary project
- Strong collaborative skills and ability to work with a
Keywords: Cytel Software Corporation, Rockville , Senior Biostatistician, Other , Rockville, Maryland
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