Associate Director, Biostatistics

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 VP 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, planning implementation 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 

• 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  

• Expert knowledge of and competence in statistical methodology (i.e. trial design, inferential statistics  statistical modelling…) 

• Expert knowledge of ICH E9 Statistical Principles for Clinical Trials 

TECHNICAL