Joule Orlando, FL
- Posted: over a month ago
- Benefits: medical, vision, dental
Permanent Biostatistician position available with a Biotechnology company.
This role will consider those with 2+ years of clinical trial experience.
Visa candidates are welcome!
- Master's Degree in Statistics (or equivalent degree) with at least 2-3 years of experience in a pharmaceutical company (pharma), biotech, or clinical research organization (CRO) servicing the pharmaceutical industry or PhD in Statistics with at least 1-2 years of experience in pharma/biotech/CRO.
- Knowledge of experimental design for clinical trials, power calculations, simulations, time-to-event analyses, and other methods for assessment of efficacy, safety, and immunogenicity.
- Familiarity with current ICH guidance pertinent to clinical development.
- Proven knowledge and expertise in biostatistics and its application to vaccine clinical trials. Solid knowledge and experience in vaccine development process, including evaluation of epidemiologic data for definition of key endpoints and assessment of correlates of risk.
- Able to thrive in a fast-paced team environment and work independently on projects.
- Very good communication and presentation skills. Ability to communicate statistical concepts across functions.
- Thorough and up-to-date working knowledge of statistical software packages. Hands-on programming experience. 1-2 years SAS programming experience (Base SAS, SAS/STAT, SAS/GRAPH, and SAS macro language) and other statistical software (e.g., R or JMP) in pharma/biotech/CRO.
- Experience with CDISC
Responsibilities include but not limited to the following:
- Assists in the review of statistical sections of clinical protocols using appropriate statistical methodology for the specific trial, including selection of study design, sample size, and analyses.
- Reviews database design, CRFs, and edit checks.
- Prepares or reviews statistical analysis plans and tables/listings/figures shells.
- Prepares or reviews statistical sections for relevant background documents for regulatory agencies.
- Writes specifications for or produce data sets, tables, figures, and listings for submissions, publications, and internal needs.
- Provides programming support to programming team when it is needed for the validation of clinical study tables and listings.
- Write codes for generating graphs for external dissemination, simulation based power calculations, and development of statistical analysis macros.
- Is a good team player. Has good business ethics and leadership skills.
- Meets deadlines while maintaining high quality standards.
- Performs other duties as requested to meet company milestones including support for Senior Manager, Biostatistics.
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