Senior Principal Biostatistician, Study Lead – Oncology

🕒 4 days ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

ClinChoice

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ClinChoice is a global full-service contract research organization (CRO) established in 1995, specializing in clinical development, post-marketing, and functional service support for the pharmaceutical, biotechnology, and medical devices industries. They provide comprehensive solutions from early clinical development to post-approval lifecycle management, with expertise in a variety of therapeutic areas such as autoimmune and inflammation, dermatology, endocrinology, infectious diseases, neuroscience, and oncology. ClinChoice aims to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. The company supports its clients with clinical, regulatory, and operational expertise across all phases of product development.

📋 Description

• Lead and provide statistical support for clinical studies, primarily within Oncology • Act as the lead statistician on assigned studies, overseeing statistical strategy and deliverables • Author and review 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 Clinical, Programming, Data Management, and Regulatory teams • Provide guidance and oversight to statistical programmers as needed • Communicate statistical concepts, results, and risks to technical and non-technical stakeholders • Ensure adherence to FDA, ICH, GCP, and company SOPs

🎯 Requirements

• MS or PhD in Statistics, Biostatistics, or a related field • Strong experience in Oncology studies • Hands-on experience writing Statistical Analysis Plans (SAPs) • Hands-on experience writing Analysis Database Specifications • Experience 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 • Preferred: Experience leading Phase II–III clinical trials • Preferred: Prior interaction with regulatory agencies • Preferred: Experience mentoring junior statisticians or programmers

🏖️ Benefits

• Professional growth opportunities • Fulfilling and rewarding career • Continuous training and development • Equal opportunity, diversity, and inclusivity