The Opportunity
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.
* 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
Who You Are
* Hold an MSc or PhD in Statistics, Biostatistics, or a closely related quantitative field
* Have experience in clinical trial statistics within a pharmaceutical, biotech, or CRO setting
* Be familiar with ICH guidelines, GCP, and regulatory requirements (e.g., FDA, EMA)
* Have a strong understanding of statistical principles and methodology relevant to clinical trial design and analysis
* Be 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
* 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 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
Location
* This position is based in Welwyn
* Relocation Assistance is not available
The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.
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