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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates advanced expertise in biostatistics, including statistical methodology, clinical study design, and regulatory submissions. Proven ability to lead cross-functional teams and provide strategic oversight in neuroscience drug development.
Highest-signal resume keywords
Pharmaceutical Industry ExperienceStatistical Computing with SAS and RClinical Study Design ExpertiseRegulatory Submission ExperienceNeuroscience Drug Development Experience
ATS Keywords
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Hard Skills
BiostatisticsStatistical MethodologyAdaptive Design MethodsDescriptive and Inferential StatisticsCDISC StandardsSDTM and ADaM DatasetsStatistical Analysis PlansClinical Study ReportsData InterpretationStatistical Programming
Soft Skills
Excellent Written and Verbal CommunicationAttention to DetailCollaboration in Diverse TeamsProblem-Solving SkillsProject and Time Management
Certifications & Qualifications
PhD in Statistics or BiostatisticsMS in Statistics or Biostatistics
Industry Keywords
FDAEMAPMDANeuroscienceDrug Development ProcessRegulatory SubmissionClinical Trial DataPortfolio Risk AssessmentCRO ManagementStatistical Defenses
About the role
Key responsibilities & impact- Serve as program-level lead biostatistician in cross-functional teams
- Provide strategic statistical support to neuroscience asset teams
- Author and review study protocols, statistical analysis plans, dataset specifications, clinical study reports, publications, and regulatory submission documents
- Lead strategic direction within neuroscience programs and influence product or business strategy
- Plan and execute biostatistics deliverables with internal and CRO team members
- Lead or support interactions with FDA, EMA, PMDA, and other health authorities
- Prepare briefing packages, meeting materials, response strategies, and statistical defenses of development decisions
- Drive adoption of adaptive designs, estimand frameworks, Bayesian approaches, and other innovative statistical methods
- Ensure rigor and accuracy in statistical planning, study design, analysis, interpretation, reporting, and presentation of clinical study results
- Evaluate and interpret clinical trial data and present results to internal and external stakeholders
- Provide strategic oversight of CROs and statistical service providers
- Support statistical analyses for regulatory documents, scientific articles, and ad-hoc exploratory analyses
- Assess resource requirements, identify portfolio risks, and develop mitigation strategies
- Contribute to team development through training, mentorship, and career development
- Lead or contribute to strategic cross-functional initiatives involving digital and data strategy, external sourcing, and internal process optimization
- Report to the Senior Director of Biostatistics, Neuroscience
Requirements
What you’ll need- 10+ years of pharmaceutical industry experience with a PhD, or 12+ years with an MS
- Advanced knowledge and practical experience of widely used clinical study designs and complex study designs
- Hands-on familiarity with common and advanced statistical methodology, including adaptive design methods
- Expertise in applying, analysing, reporting, and interpreting descriptive and inferential statistics
- Strong knowledge of statistical computing and programming principles, including SAS and R
- Hands-on experience with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets
- Excellent written and verbal communication skills
- Strong attention to detail
- Proven ability to collaborate effectively in global, cross-functional, and culturally diverse teams
- Demonstrated initiative, flexibility, and independent problem-solving skills
- Strong project and time management skills
- Deep understanding of statistical methodologies, clinical study designs, and the drug development process
- Ability to manage multiple complex projects and assess resource needs
- MS in statistics or biostatistics is required
- Fluent in English, with excellent verbal and written English
- Neuroscience drug development experience is highly desired
- Regulatory submission experience with US FDA, EMA, and PMDA is highly desired
Benefits
Comp & perks- Equal opportunity employer
- Workplace inclusion and equal opportunities
- Application-process adjustments or support for candidates who require them
- Training and career development opportunities
- Mentorship and coaching opportunities