Senior Biostatistician – Permanent role

🕒 May 15

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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ClinChoice

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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

• Provide statistical support for Phase I–IV clinical trials. • Participate in protocol development, study design, and sample size calculations. • Prepare and review Statistical Analysis Plans (SAPs), TLF shells, and randomization specifications. • Perform statistical analyses and interpret study results. • Collaborate with Clinical Data Management, Statistical Programming, Medical Writing, and Clinical Operations teams. • Review outputs, tables, listings, and figures for accuracy and consistency. • Support regulatory submissions including ISS/ISE and responses to health authority queries. • Ensure compliance with CDISC, ICH-GCP, and regulatory guidelines. • Contribute to process improvements and mentoring of junior statisticians. • Participate in client meetings and provide statistical expertise to sponsors.

🎯 Requirements

• Master’s or PhD in Statistics, Biostatistics, Mathematics, or related field. • Minimum 5–8 years of experience in biostatistics within CRO, pharmaceutical, or biotech industry. • Strong knowledge of clinical trial methodology and statistical principles. • Experience with SAS and/or R programming. • Familiarity with CDISC standards (SDTM/ADaM). • Experience supporting regulatory submissions is preferred. • Excellent communication, problem-solving, and organizational skills. • Ability to manage multiple projects and work independently

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development • Bonuses • Equipment allowances