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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in biostatistics and statistical methodologies, with a strong focus on clinical study design and regulatory submissions. Proven leadership in managing cross-functional teams and delivering high-quality statistical analyses in the pharmaceutical industry.
Highest-signal resume keywords
PhD In Statistics Or Biostatistics10+ Years Pharmaceutical Industry ExperienceSAS Programming ProficiencyLeadership Experience In BiostatisticsRegulatory Submission Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
BiostatisticsStatistical MethodologyClinical Study DesignStatistical Analysis PlansData InterpretationCDISC StandardsAdaptive Design MethodsDescriptive And Inferential StatisticsStatistical ProgrammingQuality Control
Soft Skills
Excellent Communication SkillsAttention To DetailCollaboration SkillsProblem-Solving SkillsProject Management Skills
Tools & Technologies
SASREASTNQueryJMP
Industry Keywords
Rare Disease Drug DevelopmentRegulatory AgenciesUS FDAEMAPMDA
About the role
Key responsibilities & impact- Work as program-level lead biostatistician in cross-functional teams supporting Ipsen rare disease assets
- Provide strategic support and author or review study protocols, statistical analysis plans, dataset specifications, clinical study reports, publications, and regulatory submission documents
- Provide strategic leadership and direction within rare disease programs
- Lead and coordinate planning and execution of biostatistics deliverables with internal and CRO team members
- Ensure quality, accuracy, precision, efficiency, robustness, and adherence to timelines in statistical planning and analysis
- Evaluate and interpret clinical trial data and present results to internal and external stakeholders
- Oversee and guide CRO partners on clinical data summarization approaches
- Validate and quality-control CRO statistical deliverables
- Support statistical analyses for regulatory documents and scientific articles
- Conduct internal ad-hoc and exploratory analyses
- Lead and mentor a team of biostatisticians through training, mentorship, and career development
- Contribute to departmental strategy and high-visibility cross-functional initiatives
- Support digital and data strategy, external sourcing refinement, and internal process optimization
- Participate in prospective asset evaluation and due diligence
- Collaborate with R&D functions on clinical development plans and cost and revenue modeling
- Engage with regulatory agencies and academic institutions
Requirements
What you’ll need- 10+ years of pharmaceutical industry experience with a PhD, or 12+ years with an MS
- At least 5 years in a leadership role
- MS in statistics or biostatistics is required
- Advanced knowledge and practical experience of widely used and complex clinical study designs
- Hands-on familiarity with common and advanced statistical methodology, including adaptive design methods
- Expertise in applying, analyzing, reporting, and interpreting descriptive and inferential statistics
- Strong knowledge of SAS programming concepts and techniques in the pharmaceutical industry
- Proficiency in SAS, R, EAST, nQuery, and JMP
- 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
- Strong interpersonal and relationship-building skills
- 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
- Fluent in English
- Rare disease drug development experience highly desired
- Regulatory submission experience with US FDA, EMA, or PMDA highly desired
- PhD in statistics or biostatistics strongly preferred
Benefits
Comp & perks- Equal opportunity employer
- Application adjustments or support available during the recruitment process
- Inclusive workplace committed to diverse perspectives and equal opportunities