AD/Principal Statistician (V&I- Complex Stat Analysis-PhD required)

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Associate Director/Principal Biostatistician Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality professional development and supportive culture. As a client-facing role we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Summary

We are seeking a highly experienced and academically distinguished with a strong background in vaccines and immunology. The ideal candidate will have a significant academic track record including extensive teaching and research experience and a robust publication history. This role requires advanced expertise in study design and statistical analysis particularly in the context of clinical research. Experience with FDA interactions is highly desirable.

Key Responsibilities:

• Lead and manage advanced clinical research projects focused on vaccines and immunology.

• Design and implement studies utilizing adaptive design Bayesian methods multivariate analysis regression analysis cluster analysis and factor analysis.

• Apply the Estimand framework in clinical trial designs and analysis.

• Conduct and oversee statistical analyses using MLMMs (Mixed Linear Mixed Models) LMM (Linear Mixed Models) MMRM (Mixed Model for Repeated Measures) simulations and log-likelihood functions.

• Publish research findings in high-impact peer-reviewed journals and present at scientific conferences.

• Collaborate with cross-functional teams including clinical development regulatory affairs and biostatistics.

• Engage with regulatory agencies particularly the FDA through direct interactions or consultative roles to ensure compliance and facilitate approvals.

Qualifications:

• Ph.D. in Immunology Vaccinology Biostatistics or a related field.

• Extensive experience in academia with a proven track record of teaching and research.

• A strong publication record in vaccines and immunology.

• Demonstrated experience in designing complex studies and utilizing advanced statistical techniques including adaptive design Bayesian methods multivariate analysis regression analysis cluster analysis factor analysis and simulations.

• Proficient in the application of the Estimand framework.

• Advanced knowledge of MLMMs LMM MMRM and log-likelihood functions.

• Prior experience working with or consulting for the FDA is highly desirable.

• Excellent analytical problem-solving and communication skills.

Preferred Qualifications:

• Involvement in professional organizations and committees related to immunology and biostatistics.

• Experience with data management and analysis software such as SAS R or Python

The Application Process

Once you have submitted your CV you will receive an acknowledgement that we received it. If you have the requirements we need you will be invited for phone interview as the first step.  Unfortunately due to the number of applications we receive we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical biotechnology medical device and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4000 professionals in more than 20 countries across the Americas Europe and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting developing and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender race beliefs and ethnicities. We recognize this is our strength and celebrate it.

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