Principal Biostatistician for inhouse project (Permanent role)

Responsibilities

• Lead and provide statistical support for clinical studies, primarily within Immunology or any therapeutic areas
• Act as the lead statistician on assigned studies, overseeing statistical strategy and deliverables
• Author and review key statistical documents, including:
• Statistical Analysis Plans (SAPs)
• Analysis Database Specifications (ADS)
• Statistical sections of clinical study reports
• 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
• Strong experience in Immunology or any TA clinical studies
• Hands-on experience writing:
• Statistical Analysis Plans (SAPs)
• Analysis Database Specifications
• Reviewing and interpreting analysis results
• SAS programming skills required (hands-on or strong working knowledge)
• Excellent written and verbal communication skills
• Experience working in a CRO and/or pharmaceutical/biotech environment

Requirements

• Experience leading Phase II-III clinical trials
• Prior interaction with regulatory agencies
• Experience mentoring junior statisticians or programmers
• The Application Process
• Who will you be working for?
• About ClinChoice
• Our Company Ethos
• 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

Benefits

Additional Information

ClinChoice is a global full-service CRO committed to professional growth and a quality-driven "one-team" culture. We are seeking a Clinical Project Manager II to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes. We are seeking a highly skilled Principal Statistician to lead statistical activities for clinical trials. This role requires hands-on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams. Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!

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