Company
Biotech
PrincipalBiostatisticianFSP,LatePhase
Neural analysis suggests this role is
optimal for Senior candidates.
“Principal Biostatistician FSP, Late Phase. Skills: Biostatistics, Clinical trials, Statistical analysis, Drug development. Provide statistical leadership. Support Phase II/III trials”
Industry & Context.
Analytical thinking; Problem-solving capabilities
What They're Looking For.
Must Have
PhD in Statistics or Biostatistics, 5+ years industry experience, Master's degree with 7 years experience, 3+ years supporting Phase II/III trials, Expertise in statistical methodologies, Proficiency in SAS or R, Experience developing ADaM datasets, Experience reviewing ADaM datasets, Experience developing TLFs, Experience reviewing TLFs, Experience developing statistical documentation, Experience reviewing statistical documentation, Solid knowledge of CDISC standards, Understanding of ICH E9, Understanding of ICH GCP, Understanding of regulatory requirements, Understanding of industry best practices, Experience with multiple imputation methods, Experience with advanced statistical techniques, Excellent communication skills, Excellent collaboration skills, Excellent stakeholder management skills, Ability to work independently, Ability to work proactively, Analytical thinking, Problem-solving capabilities, Attention to detail
Nice to Have
Experience interacting with health authorities, Experience participating in advisory committee activities, Experience supporting regulatory meetings, Additional experience in renal, Additional experience in nephrology, Additional experience in CNS, Additional experience in related therapeutic areas
What You'll Do.
Provide statistical leadership
Support Phase II/III trials
Ensure sound statistical methodologies
Collaborate with cross-functional teams
Establish study objectives
Establish study timelines
Establish analysis strategies
Establish data interpretation plans
Author Statistical Analysis Plans
Review Statistical Analysis Plans
Author analysis dataset specifications
Review analysis dataset specifications
Perform efficacy analyses
Oversee efficacy analyses
Perform safety analyses
Oversee safety analyses
Guide statistical programmers
Support statistical programmers
Validate analysis datasets
Quality review analysis datasets
Interpret clinical study results
Contribute statistical expertise
Support exploratory analyses
Provide statistical consultation
Participate in regulatory submissions
Support IND submissions
Support NDA submissions
Support integrated summaries
Support annual reports
Support briefing documents
Monitor project timelines
Monitor resource allocation
Monitor vendor activities
Contribute to continuous improvement
Uphold industry standards
Uphold regulatory expectations
Uphold best practices
How You'll Work.
Team & Collaboration
Cross-functional teams; Stakeholder management
Process & Methodology
Monitor project timelines, Monitor deliverables, Monitor resource allocation, Monitor vendor activities
Full Job Description
## Accountabilities Provide statistical leadership and support for Phase II and Phase III clinical trials, ensuring the application of sound statistical methodologies throughout the study lifecycle. Collaborate with cross-functional teams to establish study objectives, timelines, analysis strategies, and data interpretation plans. Author and review Statistical Analysis Plans (SAPs), analysis dataset specifications, and tables, listings, and figures (TLF) documentation. Perform and oversee efficacy and safety analyses using industry-standard statistical programming tools while ensuring the accuracy and integrity of study outputs. Guide and support statistical programmers in the development, validation, and quality review of analysis datasets and reporting deliverables. Interpret clinical study results and contribute statistical expertise to study reports, regulatory submissions, and scientific communications. Support exploratory analyses and provide statistical consultation to Clinical Development, Clinical Operations, Data Management, and related teams. Participate in regulatory submission activities, including INDs, NDAs, integrated summaries, annual reports, and briefing documents. Monitor project timelines, deliverables, resource allocation, and vendor activities to ensure successful execution of statistical deliverables. Contribute to continuous improvement initiatives and uphold industry standards, regulatory expectations, and best practices in biostatistics. Requirements PhD in Statistics, Biostatistics, or a related quantitative discipline with at least 5 years of relevant industry experience, or a Master’s degree with at least 7 years of industry experience. Minimum of 3 years of experience supporting Phase II and/or Phase III clinical trials within the pharmaceutical, biotechnology, or clinical research industry. Strong expertise in statistical methodologies applied to clinical research and drug development. Proficiency in SAS and/or R for statistical analy
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