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
