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Principal Biostatistician Jobs (NOW HIRING)

Cytel

Principal Biostatistician FSP

Cambridge, MA · On-site +1

An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead one Phase I-IV clinical studies across ...

Cytel

Principal Biostatistician FSP

Cambridge, MA · On-site

An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead one Phase I-IV clinical studies across ...

Biogen

Principal Biostatistician

Cambridge, MA · On-site

$123K - $163K/yr

As a Principal Biostatistician, you will provide project leadership in Biostatistics for specific company products or therapeutic areas. You will play a pivotal role in developing standards across ...

Cytel

Principal Biostatistician FSP

Dover, DE · On-site

An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead one Phase I-IV clinical studies across ...

Cytel

Principal Biostatistician FSP

Trenton, NJ · On-site

An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead one Phase I-IV clinical studies across ...

Biogen

Principal Biostatistician

Cambridge, MA

$123K - $163K/yr

As a Principal Biostatistician, you will provide project leadership in Biostatistics for specific company products or therapeutic areas. You will play a pivotal role in developing standards across ...

Cytel

Principal Biostatistician FSP

Dover, DE · On-site

An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead one Phase I-IV clinical studies across ...

Cytel

Principal Biostatistician FSP

Phoenix, AZ · On-site

An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead one Phase I-IV clinical studies across ...

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How much do principal biostatistician jobs pay per hour?

As of Sep 12, 2026, the average hourly pay for principal biostatistician in the United States is $84.56, according to ZipRecruiter salary data. Most workers in this role earn between $72.84 and $97.60 per hour, depending on experience, location, and employer.

What is a principal biostatistician?

A Principal Biostatistician is a senior-level professional responsible for designing, analyzing, and interpreting complex clinical trial data in the pharmaceutical, biotechnology, or healthcare industries. They provide statistical leadership, collaborate with cross-functional teams, and ensure regulatory compliance in study designs and data analysis. This role often involves mentoring junior statisticians, developing statistical methodologies, and contributing to regulatory submissions. Principal Biostatisticians play a critical role in guiding data-driven decision-making to support drug development and approval processes.

What does a principal biostatistician do?

A Principal Biostatistician is responsible for overseeing the statistical aspects of clinical trials or research projects, ensuring data integrity and regulatory compliance throughout the study lifecycle. They frequently collaborate with clinical teams, data managers, and regulatory affairs professionals to design studies, analyze data, and interpret results. This role often includes mentoring junior statisticians and contributing to strategic decisions on study design and statistical methods. The position can involve multiple concurrent projects, requiring strong organization and direct communication with both internal and external stakeholders. Successful Principal Biostatisticians play a key role in bridging technical analysis and actionable insight within cross-functional teams.

What skills and qualifications are needed to be a principal biostatistician?

To thrive as a Principal Biostatistician, you need advanced expertise in statistical methodologies, clinical trial design, and data analysis, typically backed by a graduate degree in biostatistics or a related field. Proficiency with statistical software such as SAS, R, or Python, and familiarity with regulatory guidelines are commonly required, along with relevant certifications like the SAS Certified Advanced Programmer. Strong leadership, communication, and project management skills distinguish top candidates. These capabilities are essential for ensuring scientific rigor, regulatory compliance, and effective collaboration on complex biomedical research projects.

Are principal biostatisticians in high demand?

Principal biostatisticians are in high demand due to the growth of clinical research, pharmaceutical development, and healthcare data analysis. Their expertise in statistical methods, regulatory requirements, and data management makes them valuable in both industry and academia, often leading to competitive salaries and leadership opportunities.

How much does a principal biostatistician make?

A principal biostatistician typically earns between $110,000 and $160,000 annually, depending on experience, location, and industry. Senior roles often include leadership responsibilities and require advanced statistical skills and knowledge of clinical trial design and analysis.
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Principal Biostatistician jobs near you
Infographic showing various Principal Biostatistician job openings in the United States as of September 2026, with employment types broken down into 90% Full Time, 8% Part Time, 1% Temporary, and 1% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $175,884 per year, or $84.6 per hour.

Principal Biostatistician/Senior Principal Biostatistician

Remote

Precision Medicine Group
Pharmaceutical and Medicine Manufacturing • 1 - 5K employees
Learn more about Precision Medicine Groupexternal

Full-time

Re-posted 12 days ago

Job description

Position Summary:

Provides statistical leadership and support for all phases of clinical development. Specific responsibilities include consulting with clients regarding clinical trial study design and regulatory strategy, writing and reviewing statistical methods and sample size sections of protocols, writing and reviewing statistical analysis plans of complex study designs, reviewing statistical analyses and presenting statistical results. Lead complex programs such as NDA/BLA/MAA submissions or complex, multi-protocol programs and provide statistical oversight. Serve as a subject matter expert for one or more areas (e.g., Bayesian adaptive study design, Survival analysis, DMC, submissions)

Essential functions of the job include but are not limited to:

  • Consult with clients regarding clinical trial study design and regulatory strategy
  • Develop and review statistical methods of clinical study protocols
  • Provide and/or verify sample size calculations
  • Author statistical analysis plans of complex study design
  • Review statistical analysis plans written by other biostatisticians
  • Review statistical output to ensure accuracy
  • Review statistical sections of clinical study reports
  • Generate and/or verify randomization schedules
  • Provide statistical analysis and reporting to Data Monitoring Committees (DMCs) as the unblinded reporting biostatistician
  • Work proactively with sponsors, internal study team, and external vendors
  • Serve as a Subject Matter Expert (SME) and develop/review procedural documents and work on new initiatives
  • Provide mentoring and training to other statisticians
  • Attend bid defense meetings for complex programs
  • Other duties as assigned

Qualifications:

Minimum Required:

  • Senior Principal Biostatistician level: Master's degree or equivalent in Statistics, Biostatistics, or related field with 12+ years of experience; PhD degree in Statistics, Biostatistics, or related field with 9+ years of experience
  • Principal Biostatistician level: Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years experience; PhD degree in Statistics, Biostatistics, or related field with 7+ years experience

Other Required:

  • Broad experience with regulatory submissions
  • Extensive experience consulting with clients regarding clinical trial study design and regulatory strategy
  • Superior understanding of a statistical methodology (e.g., Bayesian adaptive study design, Survival analysis, Repeated measures)
  • Sound knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
  • Experience with SAS

Preferred:

  • Experience with oncology and rare diseases
  • Experience with DMCs
  • Excellent communication and interpersonal skills
  • Excellent problem-solving skills
  • Excellent presentation skills
  • Excellent organizational and time management skills
  • Outstanding statistical skills

Competencies: 

  • Sound judgment/decision making
  • Ability to establish and teach others to maintain effective working relationships with coworkers, managers, and clients
  • Service oriented, accountable, and flexible
  • Competency in written and spoken English
  • Follow and train others on applicable regulations, including FDA, ICH, and Precision Policies and Procedures
  • At all times to promote the image of Precision, acting as an ambassador to the Company
  • Ensure that all internal systems are routinely updated as appropriate (e.g., timesheets, expense reports, financial reports, etc.) 

Apply