As Senior/Principal Statistical Scientist you are responsible for providing high-quality statistical expertise and leadership to assigned Pharma Development Medical Affairs programs and cross-functional expert groups across the Roche Pharma Development organization. You look beyond the purely statistical aspects, collaborating actively to promote rigor in the planning, conduct, and analysis of evidence generation, and in the interpretation of results.
In the clinical study setting you work closely with study team partners from biometrics, clinical science, safety science, operations, pharmacology, and regulatory. You collaborate to create strategies to address Medical Affairs evidence generation needs and design and execute appropriate studies. This includes input to protocols, review of case report forms, developing data analysis plans, and supporting the execution and interpretation of planned analyses. Effective collaboration with Medical/Clinical Science, Operations, Data Management, and Statistical Programming personnel is essential.
In this role you will be responsible for:
Medical Affairs Evidence Generation: Member of Global clinical/medical team(s), collaborating in preparation of Integrated Evidence Plans, Clinical Development Plans (or target product profiles)
Study Planning: Review study protocols, author statistical sections of protocols, develop the statistical and data analysis plans, develop independent data monitoring and endpoint committee charters.
Oversight and supervision of CRO statisticians working on study-level
Study Conduct: Review and approve analyses produced by statistical programming and CROs
Analysis & Reporting: Author the clinical study report, provide input into global health authority documents and regulatory response for health authority submissions. Contributing to study publications and presentations. Providing analytical and strategic leadership for exploratory activities such as personalized healthcare biomarker development and PK/PD modelling. Leading cross-functional teams in overseeing the generation of health authority submission datasets and associated documentation as well as participating in health authority meetings
Statistical Consulting: Provide statistical advice to Affiliates and local Medical Affairs evidence generation activities
Functional Area: Understand and apply business requirements and processes. Participates in functional training. Keeping abreast of new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, etc. Participating in Biostatistics and cross-functional initiatives. Participates in the development of functional processes. Recognized expertise in clinical trials and statistical methodology for a clinical indication and/or statistical methodology for specialized applications.
People Development and Management: Supervision and oversight of CRO statisticians; Mentor other Roche statisticians on request
Who you are
You have a MSc or PhD in statistics, biostatistics, mathematics or similar areas of academic discipline. Furthermore you bring:
Experience in using statistical software combined with good knowledge of theoretical and applied statistics
Very good knowledge and experience applying statistical methods to drug development
Deep understanding of regulatory guidelines in a pharmaceutical research setting
Effective Communication and Collaboration Skills (including statistical consulting skills, interpersonal skills to contribute effectively in cross-functional team settings, ability to influence others without authority, ability to build strong collaborative relationships with scientific and nonscientific partners)
Good Project management skills (including ability to manage scope and effectively delegate to other functions, staff, contractors and external vendors)
Good Strategic Agility (including problem-solving and critical thinking skills, ability to drive drug development strategies, agility that extends beyond statistical aspects)
Evident Drive for Results (Demonstrates interest and ability to learn new things, takes initiative, welcomes problems as challenges; finds solutions to technical problems)
Effective mentoring of other statisticians
Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a range of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.
Do you have questions? Please check our FAQs and videos on careers.roche.ch/faq.