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ClinChoice

Associate Director/Director Biostatistician_Perm-Remote

Posted 7 Days Ago
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Remote
Hiring Remotely in United States
Senior level
Easy Apply
Remote
Hiring Remotely in United States
Senior level
The Associate Director/Director Biostatistician leads statistical strategy for clinical trials, ensuring compliance with regulatory standards and collaborating with cross-functional teams on project deliverables.
The summary above was generated by AI

ClinChoice is currently recruiting for an Associate Director/Director Biostatistician to join our team in a permanent position—an exciting opportunity to lead impactful statistical strategy in a dynamic environment.  

Job Summary 1669

We are seeking an Associate Director/Director Biostatistician to provide strategic and technical leadership to support and lead statistical activities for clinical trials across multiple studies. This role requires hands-on statistical expertise, strong communication skills, and the ability to lead multiple projects while collaborating closely with cross-functional teams.

Key Responsibilities
  • Provide statistical leadership across one or more clinical programs, including study design, analysis strategy, and interpretation of results.

  • Lead the development and review of statistical deliverables, including protocols, SAPs, TFLs, ISS/ISE, and regulatory submission materials.

  • Serve as a key statistical representative in cross-functional team discussions and governance meetings

  • Ensure statistical approaches comply with regulatory standards and industry best practices.

  • Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance

  • Collaborate with cross-functional teams, including Clinical, Programming, Data Management, and Regulatory

  • Provide guidance and oversight to statistical programmers as needed

  • Communicate statistical concepts, results, and risks clearly to both technical and non-technical stakeholders

  • Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs

Required Qualifications
  • MS or PhD in Statistics, Biostatistics, or a related field

  • 10+ years of experience in biostatistics within the pharmaceutical, biotechnology, or CRO industry.

  • Strong experience supporting clinical trials across all phases.

  • Excellent communication skills, with the ability to clearly explain statistical concepts to non-statistical stakeholders.

  • Experience in attending DMC meetings (required)

  • Proven ability to lead projects and studies independently

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we have received it. If you have the requirements we need, you will be invited for a 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 industry-average turnover rates below.

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#Permanent

Top Skills

Clinical Trials
Fda
GCP
Ich
Regulatory Standards

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