Principal Biostatistician
HybridWaltham, Massachusetts, United States
Job Summary
Lead biostatistics analysis on clinical studies by writing statistical methods sections, preparing analysis plans, and performing all analyses defined in the statistical analysis plan, including post-hoc and exploratory work. Program summary tables, data listings, and graphical representations while reviewing CRFs to ensure consistency with protocols and statistical analysis plans. Mentor junior staff, manage assigned clinical study budgets, and support business development through capabilities presentations and strategic planning. Provide statistical expertise for study design, conduct statistical QC of department outputs, and represent the department at regulatory and sponsor meetings.
Required Qualifications
- Effective leadership, budget forecast and implementation skills
- Excellent analytical skills, with the ability to process scientific and medical data
- Able to work independently and in teams
- Project management abilities including analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills
- Excellent knowledge of statistical programming
- Expertise in manipulating and analyzing SAS data
- Able to identify data issues, present problems, and implement solutions
- Capable of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues and clients
- Excellent organizational and time management skills, with the ability to multi-task
- Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)
- Strong interpersonal communication and presentation skills
- Able to effectively collaborate across cross-functional teams
- Focus on quality at all times and in all situations
- Typically a Master's degree in biostatistics, statistics or other related, scientific field and four years of relevant professional experience; or a PhD in biostatistics, statistics or other related, scientific field and three years of relevant experience; or equivalent combination of experience, education, and/or demonstrated ability
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