Statistician

Roche•Boston, MA

21h•$108,200 - $201,000

About The Position

Statistician Department Summary 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 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 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. Who We Are Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. The next step is yours. To apply today, click on the "Apply for this job" button. 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. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Requirements

MSc or PhD in Statistics, Biostatistics, or a closely related quantitative field
0-2 years of relevant experience in clinical trial statistics within a pharmaceutical, biotech, or CRO setting
familiar with ICH guidelines, GCP, and regulatory requirements (e.g., FDA, EMA)
strong understanding of statistical principles and methodology relevant to clinical trial design and analysis
proficient in SAS and/or R and familiar with CDISC standards
demonstrate capacity for independent thinking and ability to make decisions based upon sound principles
bring excellent strategic agility including problem-solving and critical thinking skills, and agility that extends beyond the technical domain
demonstrate respect for cultural differences when interacting with colleagues in the global workplace
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

contributing to protocol development
authoring statistical analysis plans
performing or overseeing data analyses
supporting the interpretation and communication of results
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