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 Associate Director of Biostatistics provides statistical leadership in clinical development programs and/or supports the Director of Biostatistics and Statistical Consulting to run the department to appropriate quality standards and in line with company strategy.
KEY RESPONSABILITIES
Leads the development and execution of statistical strategy in clinical trial development, including contribution to study trial design, analysis planning, conduct and validation, study results presentation and interpretation, clinical study report authoring, regulatory submissions and publications
Supervises the activities of other biostatisticians in terms of technical aspects
Leads the internal statistical team assigned and is accountable for the quality and timeliness of the deliveries/outputs produced
Support the management of processes for biostatistical activities, including making recommendations, planningimplementation and coordinating changes
Support the development and professional growth of the resources of the department
Represents statistics both internally and externally as required
Provide support and participate to the development of proposals including Bid defense meetings as required
Provide support and participate to audit /inspections from regulatory agencies as required
Support the management of function KPIs
Manages possible complaints/CAPA/SOP deviations
Support the organization and coordination of 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
Conducts other activities as required
DESIRED QUALIFICATION & EXPERIENCE
PhD or Master’s Degree in Statistics or related field
At least 10 years of relevant industry experience in Biostatistics
At least 2 years of relevant industry experience in equivalent position with technical leadership and/or managerial accountabilities
Advanced understanding of the pharmaceutical industry and the clinical development process
Advanced Knowledge of essential regulatory guidelines worldwide
Expertknowledge of and competence in statistical methodology(i.e. trial design, inferential statistics statistical modelling…)
Expertknowledge of ICH E9 Statistical Principles for Clinical Trials
TECHNICAL COMPETENCES & SOFT SKILLS
Good Programming skills (SAS, R…)
Excellent verbal and written communications skills
Good knowledge of MS Office Suite
Strong project management skills
Strong interpersonal skills
Understanding of international cultures
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
Ability to Provide Constructive Feedback
Excellent Presentation Skills
Commercial awareness
Ability to recognize and develop talent
LanguagesEnglish
EducationDoctor of Philosophy (PhD): Statistics, Masters of Science (MS): Statistics
France
