Statistician

Roche • Boston, MA

22h

About The Position

This role is within Biostatistics, a core function within Product Development Data Science and Analytics (PDD) that provides strategic leadership and scientific rigor across Development at Roche. Biostatistics identifies opportunities to apply the full breadth of data, digital, and design capabilities to deploy innovative methods across PDD, PD and the broader Roche Pharma organization. As trusted analytical partners in end-to-end drug development, Biostatistics leverages data to drive scientifically rigorous programmatic decisions across Roche’s Development portfolio; Biostatistics designs robust trials and analysis plans that increase the probability of technical success, accelerating timelines to advance Roche’s clinical pipeline and promote regulatory success — ultimately bringing medicines to our patients faster.

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 contribute to trial design under guidance, applying standard statistical methods. You draft and review protocols, statistical analysis plans (SAPs), and case report forms (CRFs) using templates and precedents. You perform or support statistical analyses as per statistical analysis plans, escalating issues when needed. You represent Biostatistics and PDD at the Study Team level, ensuring statistical and scientific rigor of study deliverables under guidance. You collaborate with study team members to meet deliverables, following existing processes. You summarize findings clearly with support from senior colleagues. You contribute to CSR development and regulatory responses using established templates. You apply judgment to address moderately complex statistical or data issues, balancing scientific rigor with appropriate flexibility, and seek guidance when facing novel or ambiguous situations. You adhere to functional standards by participating in peer review and mentoring relationships to uphold quality and build methodological and regulatory expertise.

Requirements

• You hold an MSc or PhD in Statistics, Biostatistics, or a closely related quantitative field.
• You have 0-2 years of relevant experience in clinical trial statistics within a pharmaceutical, biotech, or CRO setting.
• You are familiar with ICH guidelines, GCP, and regulatory requirements (e.g., FDA, EMA).
• You have a strong understanding of statistical principles and methodology relevant to clinical trial design and analysis.
• You are proficient in SAS and/or R and familiar with CDISC standards.
• 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.

Nice To Haves

• Experience working in cross-functional 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).
• Excellent communication skills, including the ability to influence and translate complex data for non-technical stakeholders.
• Strategic mindset with the ability to contribute to portfolio-level decisions.

Responsibilities

• Contribute to trial design under guidance, applying standard statistical methods.
• Draft and review protocols, statistical analysis plans (SAPs), and case report forms (CRFs) using templates and precedents.
• Perform or support statistical analyses as per statistical analysis plans, escalating issues when needed.
• Represent Biostatistics and PDD at the Study Team level, ensuring statistical and scientific rigor of study deliverables under guidance.
• Collaborate with study team members to meet deliverables, following existing processes.
• Summarize findings clearly with support from senior colleagues.
• Contribute to CSR development and regulatory responses using established templates.
• Apply judgment to address moderately complex statistical or data issues, balancing scientific rigor with appropriate flexibility, and seek guidance when facing novel or ambiguous situations.
• Adhere to functional standards by participating in peer review and mentoring relationships to uphold quality and build methodological and regulatory expertise.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level