Senior Biostatistician

1w1 week ago

ClinChoice

US · Full-time · $140,000 – $180,000

About this role

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 recruiting a Senior Statistician for a permanent position to lead impactful statistical strategy.

We seek a highly skilled Senior Statistician to support and lead statistical activities for clinical trials. This role demands hands-on statistical expertise and the ability to independently lead projects. Focus primarily on studies within Immunology or any therapeutic areas.

Act as lead statistician overseeing strategy and deliverables on assigned studies. Author and review key documents like Statistical Analysis Plans, Analysis Database Specifications, and statistical sections of clinical study reports. Review and interpret analysis outputs for accuracy and regulatory compliance.

Collaborate with cross-functional teams including Clinical, Programming, Data Management, and Regulatory. Provide guidance to statistical programmers and communicate concepts clearly to stakeholders. Ensure adherence to FDA, ICH, GCP standards and company SOPs in a dynamic CRO environment.

Requirements

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, and 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

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), and 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

Benefits

Work directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring
Best of both worlds according to our team
Join a global full-service CRO specializing in clinical development for pharmaceutical, biotechnology, medical device, and consumer health companies