Principal Biostatistician
eClinical Solutions · United States
- Hybrid
- Part-time
- $175,000 / year
- United States
Tailored resume — keyword-matched to this role.
Hiring manager — we find who's hiring.
Intro email — drafted to reach them directly.
Job highlights
- Consult on statistics for clinical trials.
- Develop analysis plans and reports.
- Lead statistical programming and validation.
- Collaborate with clinical and regulatory teams.
- Analyze data for trial decisions.
About the role
Principal Biostatistician - eClinical Solutions
eClinical Solutions helps life sciences organizations accelerate clinical development with expert data services and the elluminate Clinical Data Cloud. Our platform and services provide clients with self-service access to all their data, enabling smarter, faster business decisions through advanced analytics.
Job Overview
As a Principal Biostatistician, you will provide high-level consulting services for statistical analysis, reporting, and programming within clinical trials. This includes developing protocols, statistical analysis plans, randomization schedules, conducting analyses, validating outputs, and preparing statistical analysis reports. You will also be involved in creating analysis datasets, tables, listings, and graphs for trial reporting, ensuring all client work exceeds expectations.
Your Day To Day Responsibilities
- Provide expert statistical consulting for clinical trials and fulfill study statistician responsibilities.
- Mentor and quality control statistical programmer outputs; define analysis data specifications.
- Validate statistical models used for programming and ensure accuracy.
- Act as study statistician, interacting with clients and internal teams (programmers, data managers, protocol managers).
- Ensure programmers receive correct specifications and data in a timely manner.
- Develop, review, and finalize statistical analysis plans.
- Validate programming deliverables and collaborate to resolve statistical reporting and analysis issues.
- Develop randomization schedules, specifications, and guidelines.
- Contribute to study-specific data quality control plans and ensure proper data analysis and reporting.
- Develop, validate, and finalize tables and table shells for clinical study reports.
- Address and incorporate feedback from the clinical team on statistical reports.
- Analyze data and provide input for trial progression decisions, including blinded data reviews and interim analyses.
- Collaborate on regulatory reviews, representations, and exploratory/ad-hoc/post-hoc analyses.
- Develop SAS programs for analysis datasets, tables, listings, graphs, queries, and patient profiles.
- Ensure compliance with eClinical Solutions and industry quality standards, guidelines, and procedures.
- Perform other duties as assigned.
Qualifications
- Master's degree in Statistics or Biostatistics preferred.
- SAS® certification is preferred.
- 10+ years of experience in the Pharmaceutical/Biotechnology industry or equivalent statistical consulting and SAS programming.
- Strong experience with clinical study design, analysis, and sample size determination.
- Experience developing randomization schedules, IVRS specifications, and usage guidelines.
- Excellent English communication skills (written and verbal).
- Detail-oriented with strong multitasking, prioritization, planning, and organization skills.
- Proven ability to delegate tasks and lead projects, managing multiple clinical protocols concurrently.
- Ability to balance conflicting priorities effectively.
- Strong knowledge of ICH guidelines, GCP, and 21 CFR Part 11 from FDA and EMEA.
- Experience developing statistical analysis reports and conducting analyses for various trial deliverables (blinded data reviews, interim analyses).
- Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA) and clinical reporting processes.
- Familiarity with CDISC® SDTM and ADAM data models; ability to develop ADAM for analysis and reporting.
- Thorough understanding of SDTM data structures.
About eClinical Solutions
eClinical Solutions is a fast-growing company impacting the future of healthcare. We are a winner of the 2025 Top Workplaces USA Award for Remote Work and have received numerous Top Workplaces Culture Excellence Awards for our vision, values, and work-life balance.
We are a people-first organization with an inclusive culture that values diversity and promotes innovation. We encourage continuous learning and growth. Bring your authentic self; you are welcome here!
We are an equal opportunity employer committed to diversity. Employment decisions are based on qualifications, merit, culture fit, and business need.
Key Skills/Competency
- Biostatistics
- Statistical Analysis
- SAS Programming
- Clinical Trial Design
- Data Analysis
- Regulatory Compliance
- CDISC Standards
- Statistical Reporting
- Project Leadership
- Pharmaceutical Industry
Skills & topics
- Principal Biostatistician
- Biostatistics
- Statistical Analysis
- SAS Programming
- Clinical Trials
- Data Analysis
- Pharma
- Biotechnology
- Regulatory
- CDISC
How to get hired
- Tailor your resume: Highlight your Master's in Statistics, SAS certification, and 10+ years of pharma experience. Emphasize clinical study design, analysis, and sample size determination.
- Showcase leadership: Detail your experience delegating tasks, leading projects, and managing multiple clinical protocols.
- Demonstrate technical expertise: Mention your strong knowledge of ICH, GCP, FDA/EMEA guidelines, CDISC (SDTM, ADAM), and coding dictionaries.
- Prepare for interviews: Be ready to discuss your experience with statistical analysis, reporting, SAS programming, and client consulting.
- Research eClinical Solutions: Understand their elluminate platform, data services, and commitment to a people-first, inclusive culture.
Technical preparation
Master SAS programming for analysis and reporting.,Practice clinical study design and sample size determination.,Review ICH, GCP, and 21 CFR Part 11 guidelines.,Study CDISC SDTM and ADAM data models.
Behavioral questions
Describe leading a complex statistical project.,How do you handle conflicting priorities?,Share an example of mentoring a junior statistician.,Discuss a time you ensured data quality in analysis.
Frequently asked questions
- What are the primary responsibilities of a Principal Biostatistician at eClinical Solutions?
- As a Principal Biostatistician at eClinical Solutions, you will provide high-level consulting on statistical analysis, reporting, and programming for clinical trials. This includes developing protocols, statistical analysis plans, randomization schedules, conducting analyses, validating outputs, and preparing comprehensive reports. You will also create analysis datasets, tables, listings, and graphs, ensuring all client work meets or exceeds expectations.
- What qualifications are essential for the Principal Biostatistician role?
- Essential qualifications include a Master's degree in Statistics or Biostatistics, 10+ years of experience in the pharmaceutical/biotechnology industry or equivalent, and strong SAS programming skills. Experience with clinical study design, analysis, sample size determination, randomization schedules, and regulatory guidelines (ICH, GCP, FDA, EMEA) is crucial. A SAS® certification is preferred.
- How does eClinical Solutions support professional development for its Principal Biostatisticians?
- eClinical Solutions fosters professional growth through a fast-growing environment that impacts healthcare innovation. They offer opportunities to accelerate skills and careers, emphasizing continuous learning and improvement. The company's supportive, inclusive culture and recognition as a Top Workplace for Remote Work and Culture Excellence highlight their commitment to employee development and work-life balance.
- What is the role of SAS programming in this Principal Biostatistician position?
- SAS programming is a core component of this role. You will develop SAS programs to generate analysis datasets, clinical tables, listings, graphs, patient profiles, and other trial-specific reporting deliverables. A strong proficiency in SAS is essential for conducting statistical analyses and ensuring the quality of programming outputs.
- How does eClinical Solutions approach diversity and inclusion for the Principal Biostatistician role?
- eClinical Solutions is a people-first organization that deeply values diversity and inclusion. They celebrate individual experiences, foster an inclusive culture, and believe diversity drives business success and innovation. All applicants are welcome to bring their authentic selves to work, and employment decisions are based on qualifications, merit, culture fit, and business needs.
- What is the expected compensation for a Principal Biostatistician at eClinical Solutions?
- The estimated pay range for a Principal Biostatistician at eClinical Solutions is $150,000 to $175,000 USD annually.
- What are the key regulatory guidelines this Principal Biostatistician must be familiar with?
- The Principal Biostatistician must have strong knowledge of ICH guidelines, Good Clinical Practice (GCP), and regulations such as 21 CFR Part 11 from regulatory agencies including the FDA and EMEA. Familiarity with coding dictionaries and CDISC standards (SDTM, ADAM) is also essential.
Similar roles
Open positions we recommend based on this role.