Staff Biostatistician
F
FreenomeBiotechnology
RemoteFull-TimeStaff
Salary$166,175 - $237,825
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Job Details
- Experience
- 10+ years of lead project work as a statistician on clinical trial projects.
- Required Skills
- Project ManagementPythonR
Requirements
- Master's degree or higher in Statistics, Biostatistics or Math.
- 10+ years of lead project work as a statistician on clinical trial projects.
- Expert understanding of related aspects of biostatistics processes and systems.
- Excellent written and verbal communication skills.
- Strong interpersonal and relationship management skills.
- Proven successful project management leadership skills.
- Expert understanding of clinical trial design while identifying applications of functional knowledge and methodologies to resolve complex problems.
- Experience leading briefings and technical meetings for internal and external stakeholders.
- Strong programming skills using R (required) and Python (preferred).
- Demonstrated proficiency with literate programming (R markdown/ Sweave).
- Ph.D degree or higher in Statistics, Biostatistics or Math (Nice to have).
- Experience leading IVD clinical Biostatistics to FDA submission (Nice to have).
- Knowledge of CDISC requirements preferred.
Responsibilities
- Perform in a lead Biostatistician role and provide technical expertise as a core team member of high complexity clinical studies, including statistical oversight and attending relevant project meetings.
- Provide expert level statistical guidance and thought leadership for innovative study design and clinical development plans, including endpoint selection powering.
- Develop the statistical sections of the study protocol for clinical studies.
- Interpret analysis results and ensure reporting accuracy in study reports and regulatory documents.
- Conduct overall statistical review of TFLs for clinical studies.
- Manage operations work with internal statistical programmers to ensure timeliness and quality of deliverables.
- Represent Biostatistics in interactions with regulatory authorities (e.g FDA) and during audits.
- Support the preparation of abstracts, oral presentations, manuscripts and written reports.
- Provide statistical expertise to internal and external stakeholders such as Marketing and Health Economics & Reimbursement.
- Create, maintain, and implement SOPs, processes, and work instructions.
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