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Dir, Biostatistics Oncology
• Oversees, reviews and / or executes the timely completion of high quality biostatistics deliverables for Clinical Development Plans, PCS / Protocols, Statistical Analysis Plans, Monitoring, Clinical Study Reports and Regulatory interactions for multiple studies, often as the compound lead
• May participate in PCS Reviews and Protocol Reviews providing Biostatistics comments and input
• Comprehensively assesses options and analytical strategies
• Proactively assesses risks and develops creative solutions
•Develops strategic plans for regulatory submissions
• Oversees preparation of inputs for regulatory documents for own studies
• Represents Client at Health Authority meetings
• Manages preparation of responses to Health Authorities for own studies
• Implements innovative study design and analysis methodologies for assigned studies
• Creates biostatistics standards for the Unit including SOPs, SWPs and other related technical documents
• Provides strategic input and supports exploration of methods to improve Biostatistics operational efficiency and effectiveness
Cross Functional Liaison
• Directs work with external vendors and regulatory agency with regard to electronic reporting requirements
• Provides expert guidance to clinical teams on biostatistics issues
• Manages new tools and resources (tools, systems, vendors, etc.) while minimizing their costs to the organization
• Sets key deadlines and project milestones for projects within the function
• Manages contractors and ensures that contractors, consultants and vendors complete assigned work according to agreed timelines
• Makes appropriate budgetary allocations to targeted opportunities
• Evaluates appropriateness of requests for increased budgets
• Directs the use of financial standards across work teams for consistent level of compliance
• Reviews 3rd party (contractors, consultants and vendors) work product and deliverables to approve payment of invoices and resolves discrepancies
Matrix and Team Management
• Leads by example to encourage others to prioritize personal and professional development
• Acts as a coach and mentor to staff members across units
• Participates in recruitment, selection, performance, succession, and transition activities
• Identifies team training needs and recommends solutions
People Management (if assigned direct reports)
• Manages individual contributors and / or matrixed team members and may manage people managers both locally and remotely
- Manage all employee-related activities throughout the year, including performance management and development
- Engages employees in career development conversations and aligns employees with resources and opportunities to develop
- Formally or informally assesses talent in function and enables career development opportunities for all team members
• Participates in recruitment, selection, and succession planning
• May be responsible for compensation planning for assigned employees
• Complies with all applicable laws / regulations of each country in which we do business
• Demonstrates high ethical behavior at all times, whether dealing with colleagues, vendors, patients, or physicians
• Reports legal, compliance and ethical violations in a timely manner
• PhD required with at least 10+ years of relevant experience in the pharmaceutical industry/CRO environment.
• Management experience required.
• Demonstrated excellence in statistical skills across multiple areas of pharmaceutical biostatistics, together with broad understanding and experience of the clinical development process.
• Experience with CRO oversight and FDA submission preferred.
• Excellent technical writing and verbal communication skills.
• Strong teamwork ability/commitment and individual initiative.
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