Principal Biostatistician - FSP

Fortrea; Durham (NC); Hybrid; USD 90,000 - 140,000; Full time

Job summary

Join a forward-thinking company as a Principal Biostatistician, where you will lead complex clinical trials for top pharmaceutical and biotech firms. You'll collaborate with a global team, developing Statistical Analysis Plans and providing programming support. This role offers rewarding work in a respected global company, with competitive compensation and benefits, including health insurance and flexible working hours. You'll have opportunities for training, career development, and mentorship, all while supporting a diverse and dynamic team. If you're organized, detail-oriented, and passionate about making an impact in clinical research, this position is perfect for you.

Benefits

Health Insurance

Pension Contributions

Remote Work Allowances

Flexible Working Hours

Comprehensive Onboarding

Career Development Opportunities

Mentorship Support

Qualifications

• Experience as a Lead Biostatistician in biotech, CRO, or pharmaceutical settings.
• Proficiency in SAS and statistical procedures such as non-parametric models.

Responsibilities

• Lead complex studies and coordinate activities across locations.
• Develop and review Statistical Analysis Plans and conduct senior reviews.

Skills

SAS

Statistical Procedures

Communication Skills

Clinical Trial Processes

Statistical Analysis Planning

Education

Degree in Statistics

Degree in Computer Sciences

Tools

SDTMs

ADaM Datasets

TFLs

Job description

As an experienced Principal Biostatistician in our sponsor-dedicated Flexible Solutions business unit, you will play a key role in delivering complex clinical trials for top pharmaceutical and biotech companies.

Your responsibilities include developing and reviewing Statistical Analysis Plans, providing programming support, and collaborating with a global multidisciplinary team.

About the team

You will join a long-standing partnership with a top sponsor, spanning over 10 years, and work within a team of over 150 experienced professionals worldwide, supporting global operations from the US to APAC.

What we offer

• Rewarding work in a diverse, profitable, and respected global company
• Competitive compensation, including benefits like pension contributions, health insurance, and remote work allowances
• Work-life balance and flexible working hours
• Comprehensive onboarding and mentorship
• Opportunities for training and career development
• Support from your line manager and a global network of colleagues

Your responsibilities

• Lead complex studies, coordinate activities across locations, and participate in project meetings
• Manage project resources, timelines, and milestones
• Support Data Monitoring Committees, including developing charters and attending meetings
• Develop and review Statistical Analysis Plans, and conduct senior reviews
• Review study-specific documents and develop statistical sections of protocols
• Prepare and review randomization specifications and schedules
• Mentor and train less experienced staff, review team work for accuracy
• Present at seminars, team meetings, and external conferences
• Participate in bid defenses and develop procedural documents
• Represent the department during audits

Your profile

• Degree in statistics, computer sciences, or related fields
• Experience as a Lead Biostatistician in biotech, CRO, or pharmaceutical settings
• Proficiency in SAS and statistical procedures such as non-parametric, models, categorical data, and survival analysis
• Experience with SDTMs, ADaM datasets, and TFLs
• Strong communication skills in English
• Knowledge of clinical trial processes and statistical analysis planning
• Organized, autonomous, collaborative, detail-oriented, and curious

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