Senior Principal Statistician

Genentech; Boston (MA); Hybrid; USD 130,000 - 180,000; Full time

Job summary

A leading biotechnology company is seeking a Senior Principal Statistician based in Boston to apply their extensive statistical expertise in the design, conduct, analysis, and interpretation of clinical trials. The ideal candidate holds an MSc or PhD in Statistics and has a minimum of 12 years of experience in clinical development within the pharmaceutical sector. They will lead statistical strategy for molecule programs and mentor junior staff while ensuring regulatory compliance and scientific rigor across deliverables.

Qualifications

• Minimum of 12 years of experience in clinical development within the pharmaceutical, biotech, or healthcare sectors.
• Proven ability to lead statistical input into clinical development plans and regulatory submissions.
• Experience with innovative trial designs and clinical trial methodology.

Responsibilities

• Responsible for applying statistical expertise to the design, conduct, analysis, and interpretation of clinical trials.
• Accountable for delivering robust, meaningful data for decision-making and regulatory submissions.
• Mentor junior staff and promote quality standards.

Skills

Statistical expertise

SAS proficiency

R proficiency

Clinical trial methodology

Regulatory interactions

Problem-solving

Critical thinking

Education

MSc or PhD in Statistics, Biostatistics, or related field

Tools

SAS

R

Job description

Senior Principal Statistician

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

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 are accountable for strategy and execution of all statistical aspects of a molecule program
• You ensure the application of digital, design, and data capabilities at the molecule program level
• You represent PDD on cross-functional teams, such as the Development and Lifecycle Team
• You ensure consistency, scientific rigor, and regulatory readiness of statistical deliverables, including protocols, statistical analysis plans, outputs, and submissions
• You contribute to internal and external scientific communication, including publications, presentations, and engagement with methodological communities
• You lead statistical design and strategy for the molecule CDP, developing innovative approaches aligned with program objectives
• You provide specialized expertise and best practices for study design, analysis, and interpretation, guiding cross-functional teams toward high-quality solutions
• You work independently within broad guidelines to address challenging design or analysis questions, consulting only in the most complex cases
• You interpret business or regulatory needs and recommend statistical and analytical strategies that optimize study efficiency and regulatory alignment
• You serve as a technical advisor within the disease area, mentoring statisticians and promoting quality standards and consistency
• You partner closely with clinical, regulatory, and data science teams to ensure statistical deliverables at the program level are scientifically robust, relevant, clearly communicated, and timely
• You keep abreast of new developments in drug development through evolving health authority guidance, literature review, conference attendance, and collaborative partnerships
• You drive the narrative of key results and support responses to health authority interactions
• You contribute to continuous improvement of statistical processes, templates, and tools within the function
• You mentor junior staff

Who You Are

• You hold an MSc or PhD in Statistics, Biostatistics, or a related quantitative field
• You have a minimum of 12 years of experience in clinical development within the pharmaceutical, biotech, or healthcare sector
• You have a proven ability to lead statistical input into clinical development plans and regulatory submissions
• You bring strong expertise in applying advanced statistical methods to support data-driven decision-making
• You are proficient in SAS and/or R with deep familiarity with CDISC standards and evolving regulatory data requirements
• You have a track record of leading statistical execution and delivering results in a collaborative, team-oriented environment
• You have demonstrated experience with regulatory interactions and filings
• You bring strong expertise in clinical trial methodology and statistical principles
• You are familiar with innovative trial designs
• 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
• You are able to effectively partner with stakeholders within and outside of PDD
• You understand the different subfunctions of PDD and their contributions to drug development

Preferred

• Experience working in obesity, diabetes, and cardiovascular disease
• Experience working in cross-functional global study teams
• 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

Location

• This position is based in South San Francisco and Boston

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company’s policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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