Job Purpose :
The Biostatistics and Statistical Programming (BSP) department delivers scientific excellence in statistical expertise to non-clinical and clinical vaccine development ensuring decision-making takes place within the parameters set by logical and quantitative scientific inference.
We are currently recruiting two Senior Specialist Biostatisticians. As a Senior Specialist - Biostatistician, you ensure that appropriate and efficient study / experimental designs are used in alignment with project objectives.
You are deeply involved in the continuous development of the statistical expertise and improvement of the quality and compliance of the support given by the team.
Your Responsibilities :
You are in charge to follow in close collaboration with lab scientists the statistical activities related to development, validation and life-cycle of several clinical assays.
You are involved in the design of experiments, analysis and interpretation of data and reporting (including the writing of the statistical reports and the review of documentation package).
You coordinate the different deliverables from the assays you are responsible in alignment with lab priorities, project strategy and regulatory requirements.
Your statistical expertise will be used to deliver fit-for-purpose solutions, keep the methodologies up to date and aligned with guidance.
You work in collaboration with other statisticians of the team to ensure harmonization of the statistical deliverables.
You contribute to maintain the quality framework (validation of macros, SOP, ).
Basic Qualifications :
We are looking for professionals with these required skills to achieve our goals :
At least a Master’s Degree in Biostatistics with at least 5 years’ experience within the pharmaceutical industry or equivalent experience.
Ability to master statistical methods relevant for clinical assays development and validation.
Statistical expertise to propose fit for purpose approaches and support, conduct, analyze and interpret outcomes from complex experimental studies.
Knowledge of GCLP environment.
Programming skills : SAS and / or R.
Good oral and written communication in English.
Preferred Qualifications :
If you have the following characteristics it would be a plus :
Leadership capabilities within and outside the group, give guidance to non-statisticians, provide feedback, engage.
Seeks information from the internal and external environment to understand the wider business, scientific and / or commercial context.
Function within a multisite group having team members in BE, DE and IT.
Team player and respect for deadlines.
Interactions with external international partners, regulatory agencies, academic collaborators as required by the business.