Director, Biostatistics
Asahi Kasei
Posted: 10/20/2026
Director, Channel & Distribution
Optro
Posted: 10/20/2026AWSAzureCloud
Director, Remarketing
DriveTime
Posted: 10/20/2026
Director, Platform Programs
Mercer Advisors
Posted: 10/20/2026
Associate Director, ATC Contracting and Onboarding
Miltenyi Biotec
Posted: 10/20/2026
Safety Director
Broadridge
Posted: 10/20/2026
Senior Director, HSSE Sub-division
Jones Lang LaSalle Americas, Inc.
Posted: 10/20/2026
Senior Director, Portfolio Strategy – Global Commercial Strategy, Oncology
Pfizer
Posted: 10/20/2026
Director, GPU Compilers
Samsung Electronics
Posted: 10/20/2026AndroidPythonC++
Senior Director – International Advisory Services, Affiliations
Cleveland Clinic
Posted: 10/20/2026
Director, Escalation Management
DeepHealth
Posted: 10/20/2026AWSAzureCloudGoogle Cloud PlatformITSMServiceNow
Director, Escalation Management
DeepHealth
Posted: 10/20/2026AWSAzureCloudGoogle Cloud PlatformITSMServiceNow
Director – Analytical Development, Quality Control
Kailera Therapeutics
Posted: 10/20/2026
Director, US West
Entrepreneurs' Organization
Posted: 10/20/2026
Director, Utility Field Services
Shermco Industries
Posted: 10/20/2026
Director – Personal Lines Products and Analytics
West Bend Insurance Company
Posted: 10/20/2026
Senior Associate Director, Public Policy – RCMHCP
Emory University
Posted: 10/20/2026
Director, Ad Partnership Management – Emerging & Scaled Technology Provider
Walmart
Posted: 10/20/2026
Senior Director, Revenue Cycle Management
Blackbird Health
Posted: 10/20/2026
Director, Intellectual Property
Entegris
Posted: 10/20/2026
Director, Information Technology
USAA
Posted: 10/20/2026Director, Biostatistics
Asahi KaseiPosted 10/20/2026full-timeCary • North Carolina • United StatesLead💰 $215,000 - $250,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial statistics, regulatory compliance, and strategic program oversight, with a strong focus on ICH guidelines and statistical methodologies. Proven ability to lead statistical activities, mentor team members, and effectively communicate complex statistical concepts to diverse stakeholders.
Highest-signal resume keywords
MSc Or PhD In Biostatistics Or Statistics10–15+ Years Of Experience In Clinical Trial StatisticsExpertise In SASStrong Working Knowledge Of ICH, FDA, And EMA Regulatory GuidelinesExperience With Adaptive Or Innovative Designs
About the role
Key responsibilities & impact- Serve as the primary statistical point of contact for one or more clinical development programs
- Provide strategic input into clinical development plans, target product profiles, and overall program strategy
- Ensure statistical consistency and alignment across all clinical studies in a program
- Advise on quantitative decision-making, including go/no-go criteria, dose selection, and adaptive design strategies
- Collaborate with Clinical Development to design scientifically sound and efficient clinical trials from First in Human through registration
- Oversee and review statistical sections of protocols, SAPs, and mock TLFs
- Recommend statistical methodologies, estimands, and endpoints supporting program objectives
- Oversee statistical and programming activities conducted by CROs and external vendors
- Ensure deliverables meet quality expectations, timelines, and regulatory standards
- Provide direction and accountability for outsourced statistical work and escalate complex statistical issues
- Work with Data Management on data collection standards, CDISC compliance, and data structures for cross-study analysis
- Contribute to integrated database planning and integration of external or real-world data when applicable
- Anticipate data needs for interim analyses, adaptive trials, and regulatory interactions
- Interpret and communicate statistical results to clinical, regulatory, and senior leadership stakeholders
- Ensure analyses support regulatory strategy, scientific publications, safety evaluations, and internal decision-making
- Lead statistical components of IND, CTA, BLA, and MAA regulatory submissions
- Prepare statistical responses to health authority questions and attend regulatory meetings as statistical representative
- Ensure compliance with ICH guidelines, regulatory expectations, and best practices in clinical statistics
- Contribute to cross-functional development teams, safety review committees, and governance meetings
- Translate complex statistical concepts into actionable insights for non-statisticians
- Mentor and guide study statisticians and junior team members
Requirements
What you’ll need- MSc or PhD in Biostatistics or Statistics
- 10–15+ years of experience in clinical trial statistics within biotech/pharma
- Proven track record of leading statistical activities across multiple studies or programs
- Strong working knowledge of ICH, FDA, and EMA regulatory guidelines and statistical principles in drug development
- Expertise in SAS
- Ability to balance hands-on work with strategic program oversight in a fast-paced biotech environment
- Excellent communication, leadership, and problem-solving skills
- Familiarity with R is beneficial
- Demonstrated ability to manage CROs and external statistical partners
- Experience with adaptive or innovative designs
- Exposure to early-stage development or rare/complex diseases
- Ability to influence senior stakeholders and drive strategic decisions
- Strong collaboration mindset with high attention to scientific and operational quality
- Experience using real-world data to support programs
- Experience collaborating with Medical Affairs
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial StatisticsStatistical MethodologiesData AnalysisStatistical ProgrammingRegulatory SubmissionsStatistical ProtocolsAdaptive Design StrategiesData Collection StandardsStatistical EndpointsReal-World Data Analysis
Soft Skills
Excellent CommunicationLeadership SkillsProblem-Solving SkillsCollaboration MindsetAbility To Influence Stakeholders
Tools & Technologies
SASRCDISC ComplianceStatistical Analysis SoftwareIntegrated Database Planning
Industry Keywords
BiotechPharmaClinical DevelopmentRegulatory ComplianceINDCTABLAMAASafety EvaluationsComplex Diseases