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832#Associate Director, Biostatistics(TA-Autoimmune and Inflammatory Diseases)_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 currently recruiting for a Associate Director of Biostatistics to join our client’s team in a permanent position—an exciting opportunity to lead impactful statistical strategy in a dynamic environment.

SF Bay Area preferred 
Will consider remote candidates – Pacific Time zone preferred
This is a support role as study statistician

We are seeking an Associate Director of Biostatistics to provide statistical expertise and operational support across a variety of clinical activities with a focus on supporting early-stage and late-stage clinical programs.  This role will serve as lead study statistician, collaborating with cross-functional teams to support clinical development and data-driven decision-making. The Associate Director will contribute hands-on to key deliverables, manage CROs, and provide guidance to junior team members. 

Essential Responsibilities: 
• Contribute to the statistical design and analysis of early and late phase clinical studies. 
• Apply advanced statistical methods and data visualization skills to clinical trial data summaries 
and interpretations such as integrated safety and efficacy analyses for regulatory submissions. 
• Serve as the biostatistics representative on cross-functional teams, ensuring alignment of 
statistical approaches with study and program objectives. 
• Provide input on study design, endpoint selection, and sample size planning. 
• Draft statistical analysis plans (SAPs) and support interpretation of results. 
• Ensure the quality and accuracy of statistical deliverables by independently generating the 
statistical deliverables and/or independently reviewing and validating the statistical 
deliverables generated by either CRO or internal statistical programming team. 
• Manage CROs and mentor junior staff or contractors as appropriate. 

The Ideal Candidate: 
Education: 
• Ph.D. in Biostatistics with 6+ years of relevant industry experience, or Master’s with 8+ years 

Experience 
Strong foundation in clinical trial design, statistical analysis, and regulatory guidelines. 
• Experience in publication work and/or analysis of real-world data preferred. 
• Proficiency in statistical programming (SAS and R). 
• Immunology or related therapeutic area experience a plus. 
• Demonstrated ability to manage multiple priorities and work cross-functionally. 
• Experience with both early-stage and late-phase clinical trials in biotech/pharmaceutical industry is preferred.

Skills: 
• Strong analytical thinking and attention to detail. 
• Excellent verbal and written communication skills. 
• Ability to work independently in a fast-paced, regulated environment. 
• Ability to manage deliverables with competing priorities and influence others effectively. 
• Strong organizational skills, with the ability to manage workflows and activities to meet 
department timelines. 
• Collaborative mindset and ability to influence without authority. 

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 #AssociateDirector#permanent

 

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