We are seeking a Biostatistician to help with clinical study analysis and medical writing; power analysis and trial design in support of FDA filings; and cross-departmental statistical support for our clinical, lab, and informatics teams. This role will not be boring! Success will lead to numerous publications, successful FDA interactions, and career growth opportunities. On-the-job learning and a desire to say ‘yes’ to new things are expected.
- Participate in the design of clinical trials and case report forms, and provide sample size calculations and statistical methodology for study protocols
- Analyze data for registrational and non-registrational prospective and retrospective studies, write statistical reports for integration into clinical study reports, and describe your work in drafting clinical abstracts and manuscripts
- Perform data review and database clean-up, perform data analyses, and review clinical study reports for registrational submissions
- Work collaboratively with others on statistical issues in Pre-IDE submissions and in response to FDA queries after submissions until the final market approval
- Statistical support for lab team, mainly experiment design
- Statistical support for informatics team, mainly exploratory data analysis
- BA/BS degree in relevant field and at least five years’ industry experience. MS/PhD a plus but not required.
- Prior experience working with clinical data and/or clinical trials analysis, including mixed models and random effects models
- Experience using R
- History of manuscript/abstract publications
- Background in Bayesian statistics is a plus
KNOWLEDGE, SKILLS, AND ABILITIES:
- Excellent verbal and written communication
- Good data visualization skills
- Knowledge of infectious diseases or emergency or ICU medicine a plus but not required
- Excited to ‘wear many hats’, and self-motivated to take on new challenges
- Track record of success in a deadline-driven and multi-task environment
- Well organized and detailed oriented
- Ability to work in diverse team settings with a top-notch scientific team
SALARY AND CLASSIFICATION:
- Compensation: Competitive and commensurate with experience; includes equity package.
HOW TO APPLY: Please forward a cover letter and resume to: jobs [at] inflammatix [dot] com