We are seeking an experienced Biostatistician to perform 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. The candidate will be part of the Clinical Affairs team and report into the Chief Medical Officer.
PRIMARY RESPONSIBILITIES:
• 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
• Provide statistical support for lab team, mainly experiment design
• Provide statistical support for informatics team, mainly exploratory data analysis
• Collaborate with informatics team on machine learning analyses of immune response data
QUALIFICATIONS:
• MS/PhD degree in relevant field
• At least five years’ industry experience are 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:
• Classification: Full-time position. The role can be located anywhere in the world during the COVID19 pandemic. Post-pandemic, the role is expected to be located in Burlingame, CA.
• Compensation: Competitive and commensurate with experience; including equity package.
• Generous benefits consistent with location norms. For example, US-based role would include medical, dental, and vision; 401(k) and more.
PRIMARY RESPONSIBILITIES:
• 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
• Provide statistical support for lab team, mainly experiment design
• Provide statistical support for informatics team, mainly exploratory data analysis
• Collaborate with informatics team on machine learning analyses of immune response data
QUALIFICATIONS:
• MS/PhD degree in relevant field
• At least five years’ industry experience are 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:
• Classification: Full-time position. The role can be located anywhere in the world during the COVID19 pandemic. Post-pandemic, the role is expected to be located in Burlingame, CA.
• Compensation: Competitive and commensurate with experience; including equity package.
• Generous benefits consistent with location norms. For example, US-based role would include medical, dental, and vision; 401(k) and more.