Senior Biostatistician

Location: Remote (USA / Canada)

The Opportunity:

The Statistician is a key member of the cross-functional study or molecule team, responsible for applying statistical expertise to the design, conduct, analysis, and interpretation of individual clinical trials. This role ensures the scientific rigor and regulatory compliance of the study by contributing to protocol development, authoring statistical analysis plans, performing or overseeing data analyses, and supporting the interpretation and communication of results. The Statistician plays a critical role in ensuring that each study generates robust, meaningful data to support decision-making and regulatory submissions.

- You independently lead statistical input into clinical trial design, aligning with scientific objectives
- You own the development and quality review of statistical study documents
- You design and execute complex analyses, proactively resolving challenges
- You represent Biostatistics and PDD at the Study Team level, ensuring statistical and scientific rigor of study deliverables
- You collaborate proactively with cross-functional teams to align deliverables and timelines
- You interpret and communicate results in context, influencing study-level decisions
- You lead statistical contributions to CSRs and selected regulatory documents
- You provide functional guidance and informal mentoring to less experienced statisticians
- You may lead or influence study-level projects or contribute significantly to large project teams or initiatives

Who You Are:

- You hold an MSc or PhD in Statistics, Biostatistics, or a closely related quantitative field
- You have a minimum of 3 years of relevant experience in clinical trial statistics within a pharmaceutical, biotech, or CRO setting
- You have demonstrated experience contributing to the design, analysis, and interpretation of clinical studies across different phases
- You have a solid understanding of regulatory expectations and statistical methodologies for clinical development
- You are proficient in SAS and/or R and familiar with CDISC standards
- You are able to work autonomously while collaborating effectively in cross-functional teams
- You demonstrate capacity for independent thinking and ability to make decisions based upon sound principles
- You bring excellent strategic agility including problem-solving and critical thinking skills, and agility that extends beyond the technical domain
- You demonstrate respect for cultural differences when interacting with colleagues in the global workplace
- You have excellent verbal and written communication skills, specifically in the areas of presentation and writing, with the ability to explain complex technical concepts in clear language

Preferred:

- Experience working in cross-functional global study teams.
- Effective communication skills with the ability to translate complex statistical concepts for non-statistical audiences.
- Experience with multiple phases of drug development (early and/or late stage).
- Experience in mentoring or scientific leadership within a matrix organization.
- Strategic mindset with the ability to contribute to portfolio-level decisions

Must have:

- 5+ years' experience in Biostatistics & SAS
- Experience with Late Phase
- Independent trial statistician experience
- Would be good to have R