Senior Director Biostatistics and Statistical - Paris, France - Alira Health
Description
Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration.
Where all contributions and new ideas are explored with an open mind and work is driven by our shared values:be courageous, be accountable, be honest, be inclusive and elevate others.
Job Description Summary
Job Description:
ROLE
The Senior Director of Biostatistics runs the Biostatistics department efficiently, to appropriate quality standards and in line with company strategy acting as the Qualified Statistical Manager according to Clause 6 of the Italian CRO decree dated 15 Nov.
- KEY RESPONSABILITIES
- Reports problems and critical issues to the SVP Biometrics Operations
- Supervises the activities of the other biostatisticians terms of technical aspects
- Leads the internal statistical team and is accountable for the quality and timeliness of the deliveries/outputs produced
- Manages the headcount for the group based on current and likely future workloads
- Support the management of processes for biostatistical P activities, makes recommendations, plans implementation and coordinates changes
- Ensures appropriate training for the members of the department
- Manages function KPIs, implements solutions to address KPI failures
- Properly develops professional growth of the resources of the department
- Takes accountability for recruitment
- Is responsible for keeping uptodate the processes related to statistical activities
- Provides support to Business Development during client meetings to understand the needs and to provide the most appropriate service
- Provide support and participate to Bid defense meeting as required
- Provide support and participate to audit from Sponsor or inspections from regulatory agencies as required
- Manages function KPIs
- Manages possible complaints/CAPA/SOP deviations
- Organizes and coordinates meetings with the members of the biostatistics department to share information and discuss issues
- Ensures alignment of team members objectives with company strategies and objectives
- Provides support for presentations to potential clients
- Raises external profile of Alira Health biostatistics
- Provides strategic input for the preparation of Budget Proposals
- Acts as Biometrics Operation Executive (BOE) for the assigned clients
- Conducts other activities as requiredDESIRED QUALIFICATION & EXPERIENCE
- PhD or Master's Degree in Statistics or related field
- At least 15 years of relevant industry experience in Biostatistics
- At least 5 years of relevant industry experience in equivalent position with technical leadership and managerial accountabilities
- Advanced understanding of the pharmaceutical industry and the clinical development environment
- Advanced knowledge of essential regulatory guidelines worldwide
- Expert knowledge of and competence in statistical methodology
- Expert knowledge of ICH E9 Statistical Principles for Clinical Trials
- TECHNICAL COMPETENCES & SOFT SKILLS
- Good programming skills (SAS, R,..)
- Excellent verbal and written communication skills
- Good knowledge of MS Office Suite
- Strong project management skills
- Understanding of international cultures
- Strong interpersonal skills
- Professional
- Trustworthy
- Ability to effectively prioritize
- Quality focused
- Personable Attitude
- Willingness to learn
- Team Player
- Effective Stress Management Techniques
- Learning Agility
- Ability to Manage Conflict
- Problem Solving Skills
- Effective Verbal Communication Skills
- Commercial and Technical Writing Skills
- Networking Skills
- Analytical thinking
- Resilient
- Ability to Influence and motivate
- Ability to manage difficult conversations
- Innovative
- Ability to Provide Constructive Feedback
- Excellent Presentation Skills
- Commercial awareness
- Ability to recognize and develop talentLanguages
Education
Doctor of Philosophy (PhD): Statistics, Masters of Science (MS): Statistics
Contract Type
Regular
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