This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Principal Biostatistician in United States.
This role sits at the forefront of early-phase oncology clinical research, driving statistical strategy and execution across complex Phase I–II studies. You will lead statistical activities that directly support clinical development programs, regulatory submissions, and client-facing engagements. Working in a highly collaborative, global research environment, you will provide expert input into study design, protocols, statistical analysis plans, and clinical study reports. The position requires strong leadership in guiding study teams, ensuring methodological rigor, and maintaining high scientific and regulatory standards. You will also play a key role in client interactions, bid defenses, and strategic program discussions, contributing to the success of innovative oncology therapies. This is a high-impact role combining technical depth, regulatory expertise, and leadership within a fast-paced clinical research organization.
Accountabilities:- Act as lead biostatistician across oncology Phase I–II clinical trial programs, including complex multi-study initiatives and regulatory submissions.
- Oversee the development and review of statistical components such as protocols, SAPs, mock shells, and clinical study reports.
- Provide expert statistical guidance and ensure compliance with regulatory expectations for clinical trial design and analysis.
- Program and validate statistical analyses using SAS and/or R for inferential and advanced modeling needs.
- Participate in client meetings, bid defenses, and regulatory interactions, delivering clear and authoritative statistical insights.
- Mentor and support junior statisticians, fostering technical growth and quality standards within the team.
- Contribute to process improvement initiatives and development of internal statistical standards and best practices.
- Ensure timely delivery of high-quality statistical outputs across multiple concurrent studies.
Requirements:
- Master’s or Ph.D. in Biostatistics, Statistics, or a related quantitative field.
- Minimum of 8 years of experience in biostatistics, preferably within clinical research or a CRO environment.
- Proven experience leading Phase I/II oncology clinical trials, including client-facing responsibilities.
- Strong regulatory experience, including support for submissions such as NDAs or equivalent filings.
- Advanced proficiency in statistical programming using SAS and/or R.
- Ability to design, supervise, and manage statistical processes across multiple clinical studies.
- Excellent communication skills with demonstrated leadership and stakeholder management abilities.
- Strong organizational, prioritization, and time management skills in a fast-paced environment.
Benefits:
- Competitive salary with performance-based compensation structures.
- Comprehensive health, dental, and vision insurance options for employees and families.
- Retirement savings plans to support long-term financial security.
- Generous paid time off and country-specific leave entitlements.
- Life assurance and employee assistance programs supporting well-being and mental health.
- Flexible benefits such as childcare support, gym memberships, travel assistance, and wellness programs.
- Remote work flexibility within the United States or Canada.
- Inclusive, international work environment focused on collaboration, diversity, and professional growth.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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