Lead and operationally manage a biostatistics group, provide strategic statistical consultancy, oversee project progress and finances, drive process improvements, mentor staff, ensure CDISC compliance, peer-review SAPs, support business development and regulatory interactions, and implement staffing and operational strategies.
Premier Research is looking for a Senior Director, Biostatistics to join our Biostatistics team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
What you'll be doing:
- Ability to manage and de-escalate difficult situations with clients, teams, and management
- Demonstrated critical thinking with a history of bringing forward strategic initiatives
- Capability and willingness to coach and mentor others
- Ability to lead process improvement efforts
- Develop and maintain overall awareness in the field of biostatistics by reading related literature, attending training classes, professional meetings, statistical conferences etc.
- Integrates operations between Biostatistics and other departments to obtain increased productivity, efficiency and quality
- Provides oversight and reporting of project progress and financial health within Biostatistics
- Develops and implements strategies to actualize goals
- Strategic responsibility for all staffing and operational aspects of the allocated Biostatistics group
- Provides consultancy to sponsors on statistical issues
- Peer reviews draft statistical analysis plans and provides feedback
- Support business development through participation in bid defenses, capabilities presentations, RFP strategy and build trusted scientific relationships with sponsors and influence decision-making through evidence-based recommendations.
What we're looking for:
- Advanced degree (MS or PhD) from accredited college or university, in statistics or closely related field. Equivalent combination of education, training and experience will be considered.
- 12+ years’ experience in clinical trials design and analysis
- 7+ years’ experience as supervisor/manager
- Excellent demonstrated working knowledge of basic clinical trial design and analysis principles.
- Excellent working knowledge of CDISC standards and application of these standards to projects.
- Excellent working knowledge and understanding of advanced statistical concepts
- Strong computer skills, with evidence of advanced SAS programming skills especially statistical inferential procedures
- Demonstrated experience in interacting with regulatory agencies (e.g. FDA, EMA, EU member states)
- Ability to motivate and lead a team of varying levels of status and ability
Specific experience in Rare Disease/Specialty is highly desirable
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status
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