Principal Biostatistician

United States Digital Space LLC; United States; Hybrid; USD 150,000 - 210,000; Full time

Benefits offered by this job

Flexible remote-friendly working

Competitive compensation

Comprehensive benefits

Global team collaboration

Job summary

United States Digital Space LLC seeks a Principal Biostatistician to lead the design, analysis, and delivery of complex clinical trials, supporting global programs from study design through regulatory submissions and beyond.

Working within our Full Service team, you will partner with multidisciplinary stakeholders and provide strategic statistical leadership to ensure high-quality, impactful outcomes.

Qualifications

• Advanced degree in statistics/biostatistics with leadership experience in CRO/biotech/pharma.
• Strong regulatory knowledge for FDA/EMA submissions and studies.
• Ability to communicate complex statistics to diverse stakeholders.

Responsibilities

• Lead statistical strategy and delivery for complex studies and programs (submissions, multi-protocol).
• Develop and review SAPs and ensure quality of statistical outputs.
• Oversee analyses, TFLs, and study reporting; mentor statisticians.
• Collaborate across cross-functional teams and represent Biostatistics in client interactions.
• Support regulatory interactions, publications, and post hoc analyses.
• Contribute to study design, protocols, and randomization planning.
• Represent Biostatistics in audits and bid defenses.

Skills

Biostatistics leadership

Clinical trials statistics

Regulatory knowledge FDA/EMA

English fluency

Cross-functional collaboration

Education

MSc/PhD in Statistics/Biostatistics

Tools

SAS Advanced

CDISC SDTM/ADaM

Job description

As a Principal Biostatistician at the company, you will play a key role in the design, analysis, and delivery of complex clinical trials, supporting global programs from study design through to regulatory submissions and beyond.

Working within our Full Service team, you will partner with multidisciplinary stakeholders and provide strategic statistical leadership to ensure high-quality, impactful outcomes.

Your responsibilities:

• Lead statistical strategy and delivery for complex studies and programs (including submissions and multi-protocol work)
• Develop and review Statistical Analysis Plans and ensure quality of statistical outputs
• Provide oversight of statistical analyses, Tables, Figures & Listings (TFLs), and study reporting
• Collaborate closely with cross-functional teams and act as a key statistical advisor
• Support regulatory interactions, publications, and post hoc analyses
• Contribute to study design, protocols, and randomization planning
• Mentor junior statisticians and provide technical leadership
• Represent Biostatistics in client interactions, bid defenses, and audits

Your experience and qualifications:

• Advanced degree (MSc/PhD) in Statistics, Biostatistics, or related field
• Significant experience as a Lead/Principal Biostatistician in CRO, biotech, or pharma
• Strong knowledge of statistical methods for clinical trials and regulatory requirements (FDA/EMA)
• Proficiency in SAS (including advanced procedures)
• Solid experience with CDISC standards (SDTM, ADaM, TFLs)
• Ability to communicate complex statistical concepts to diverse stakeholders
• Strong organizational skills, attention to detail, and collaborative mindset
• Fluent in English

What you can expect from us:

• Work on complex, high-impact global studies
• Strong career development and growth opportunities
• Competitive compensation and comprehensive benefits
• Flexible, remote-friendly working environment
• Supportive, collaborative team culture

the company is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about the company, visit .

the company is proud to be an Equal Opportunity Employer:As an EOE/AA employer, the company strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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