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Lead/Principal Statistician Consultant-Medical Affairs (remote)

United States

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 Principal Biostatistician Consultant -Medical Affairs 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.  

Position Summary:
ClinChoice is seeking a highly experienced Principal Biostatistician to support Client Medical Affairs team. This role is critical in providing statistical leadership, strategic input, and operational support across post-marketing studies, real-world evidence (RWE), and other medical affairs initiatives. The ideal candidate will have a strong background in biostatistics, deep understanding of clinical research, and hands-on experience supporting cross-functional teams in a pharmaceutical or biotech environment.

Key Responsibilities:
Serve as the lead biostatistician for Medical Affairs projects, including Phase IV studies, observational studies, registries, and RWE analyses.
Provide statistical expertise in study design, protocol development, analysis planning, and reporting.
Collaborate with cross-functional teams including Medical Affairs, HEOR, Clinical Development, Data Management, and Regulatory Affairs.
Guide the statistical aspects of scientific publications, conference presentations, and regulatory submissions.
Oversee statistical deliverables from CROs or external partners to ensure quality and compliance with internal standards.
Develop and review statistical analysis plans (SAPs), table shells, and other relevant documentation.
Ensure adherence to ICH guidelines, regulatory requirements, and internal SOPs.
Mentor junior biostatisticians and provide technical guidance where needed.
Support audits and inspections by regulatory bodies when applicable.

Required Qualifications:
Ph.D. or Master’s degree in Biostatistics, Statistics, or a related quantitative field.
Minimum of 8+ years (PhD) or 10+ years (Master’s) of experience in the pharmaceutical, biotech, or CRO industry.
Strong experience in Medical Affairs, post-marketing studies, or real-world data (RWD)/real-world evidence (RWE).
Proficiency in SAS and/or R for statistical programming and analysis.
In-depth knowledge of GCP, ICH guidelines, and relevant regulatory frameworks.
Proven ability to collaborate effectively across functional areas and communicate complex statistical concepts to non-statistical audiences.
Experience with publication planning and manuscript development is a strong plus.

Preferred Qualifications:
Prior experience in oncology, immunology, neurology, or other therapeutic areas of focus at client.
Familiarity with data sources such as claims databases, electronic health records (EHRs), or registries.
Experience managing CROs or external vendors.

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 4,000 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.


#LI-TT1 #LI-Remote #Principal#Contract

 

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