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Principal Biostatistician/Senior Principal Biostatistician
Precision Medicine GroupProviding statistical leadership and support for clinical development at Precision Medicine Group. Handling complex programs and regulatory submissions with expert oversight.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in statistical leadership and clinical trial design, with a strong focus on regulatory strategy and statistical methodology. Proficient in mentoring and providing statistical analysis for clinical development, ensuring compliance with industry standards.
Highest-signal resume keywords
Statistical LeadershipClinical Trial Study DesignRegulatory SubmissionsStatistical MethodologySAS Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Statistical AnalysisSample Size CalculationStatistical Analysis Plan AuthoringBayesian Adaptive Study DesignSurvival AnalysisRepeated Measures
Soft Skills
ConsultingMentoringCollaboration
Tools & Technologies
SAS
Industry Keywords
ICH GuidelinesCDISC Data Structures21 CFR Part 11FDA Guidelines
About the role
Key responsibilities & impact- Provides statistical leadership and support for all phases of clinical development
- Consulting with clients regarding clinical trial study design and regulatory strategy
- Developing and reviewing statistical methods of clinical study protocols
- Providing and/or verifying sample size calculations
- Authoring statistical analysis plans of complex study design
- Reviewing statistical analysis plans written by other biostatisticians
- Reviewing statistical output to ensure accuracy
- Reviewing statistical sections of clinical study reports
- Generating and/or verifying randomization schedules
- Providing statistical analysis and reporting to Data Monitoring Committees (DMCs) as the unblinded reporting biostatistician
- Working proactively with sponsors, internal study team, and external vendors
- Serving as a Subject Matter Expert (SME) and developing/reviewing procedural documents and working on new initiatives
- Providing mentoring and training to other statisticians
- Attending bid defense meetings for complex programs
Requirements
What you’ll need- 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
- 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
Benefits
Comp & perks- discretionary annual bonus
- health insurance
- retirement savings benefits
- life insurance
- disability benefits
- parental leave
- paid time off for sick leave and vacation