Principal Biostatistician-- work remotely
Job Description
Principal Biostatistician
Position Overview
We are seeking an experienced Principal Biostatistician to provide statistical consultation for clinical development programs and to support clients in the auto-immune disease area.
The successful candidate will play a key role in study design, statistical analysis, regulatory interactions, and cross-functional collaboration throughout the clinical development lifecycle.
This position requires strong scientific judgment, excellent communication skills, and the ability to work effectively in a fast-paced biotech environment.
Key Responsibilities
Statistical Leadership
• Lead statistical strategy for clinical development programs from Phase I through Phase III
• Provide hands-on support to delivery to clinical study protocols, statistical analysis plans (SAPs), specs to TFL outputs, SDTM/ADAM specs, and clinical study reports (CSRs)
Study Design & Analysis
• Design clinical trials including sample size calculations, randomization schemes, and interim analysis planning
• Perform or oversee statistical analyses using SAS or R
• Interpret statistical results and communicate findings to cross-functional teams
Regulatory & Documentation
• Ensure statistical deliverables meet FDA requirements
• Contribute to regulatory submissions including IND, NDA, and BLA
• Support interactions with regulatory agencies such as the FDA and EMA
Cross-Functional Collaboration
• Collaborate with clinical development, statistical programming, data management, and regulatory teams
• Provide statistical guidance to internal teams and external biotech partners
Qualifications
Education
• PhD or MS in Statistics, Biostatistics, or related quantitative discipline
Experience
• PhD with 5+ years of industry experience, or MS with 7+ years
• Experience supporting clinical trials in the pharmaceutical or biotech industry
• Experience with regulatory submissions are preferred, but not must
Technical Skills
• Proficiency in SAS and/or R
• Experience with clinical trial design and statistical methodology
• Familiarity with CDISC standards (ADaM/SDTM) is a must
Soft Skills
• Strong communication and presentation skills
• Ability to work independently and manage multiple projects
• Experience working in a biotech or consulting environment is highly preferred
What We Offer
• Opportunity to work with innovative biotech companies globally
• Exposure to diverse therapeutic areas and development programs
• Flexible remote work environment
• Collaborative and entrepreneurial culture
Job Type: Contract
Pay: $250,000.00 - $300,000.00 per year
Schedule:
• Monday to Friday
Work Location: Remote
Apply tot his job
Apply To this Job
Principal Biostatistician
Position Overview
We are seeking an experienced Principal Biostatistician to provide statistical consultation for clinical development programs and to support clients in the auto-immune disease area.
The successful candidate will play a key role in study design, statistical analysis, regulatory interactions, and cross-functional collaboration throughout the clinical development lifecycle.
This position requires strong scientific judgment, excellent communication skills, and the ability to work effectively in a fast-paced biotech environment.
Key Responsibilities
Statistical Leadership
• Lead statistical strategy for clinical development programs from Phase I through Phase III
• Provide hands-on support to delivery to clinical study protocols, statistical analysis plans (SAPs), specs to TFL outputs, SDTM/ADAM specs, and clinical study reports (CSRs)
Study Design & Analysis
• Design clinical trials including sample size calculations, randomization schemes, and interim analysis planning
• Perform or oversee statistical analyses using SAS or R
• Interpret statistical results and communicate findings to cross-functional teams
Regulatory & Documentation
• Ensure statistical deliverables meet FDA requirements
• Contribute to regulatory submissions including IND, NDA, and BLA
• Support interactions with regulatory agencies such as the FDA and EMA
Cross-Functional Collaboration
• Collaborate with clinical development, statistical programming, data management, and regulatory teams
• Provide statistical guidance to internal teams and external biotech partners
Qualifications
Education
• PhD or MS in Statistics, Biostatistics, or related quantitative discipline
Experience
• PhD with 5+ years of industry experience, or MS with 7+ years
• Experience supporting clinical trials in the pharmaceutical or biotech industry
• Experience with regulatory submissions are preferred, but not must
Technical Skills
• Proficiency in SAS and/or R
• Experience with clinical trial design and statistical methodology
• Familiarity with CDISC standards (ADaM/SDTM) is a must
Soft Skills
• Strong communication and presentation skills
• Ability to work independently and manage multiple projects
• Experience working in a biotech or consulting environment is highly preferred
What We Offer
• Opportunity to work with innovative biotech companies globally
• Exposure to diverse therapeutic areas and development programs
• Flexible remote work environment
• Collaborative and entrepreneurial culture
Job Type: Contract
Pay: $250,000.00 - $300,000.00 per year
Schedule:
• Monday to Friday
Work Location: Remote
Apply tot his job
Apply To this Job