Senior Statistical Scientist

About the role

Sobi develops and delivers innovative therapies for people living with rare diseases. The Senior Statistical Scientist provides experienced statistical, scientific and strategic support across assigned studies or indications, with broader responsibility and greater independence than a Statistical Scientist. The role is typically taken as Study Statistician for multiple complex or business-critical studies, but can also be a Program Statistician.

Key responsibilities

• Ensure the quality and timely delivery of statistical analyses for assigned studies in line with Sobi SOPs and regulatory requirements
• Lead in-house consultants and CRO statisticians on assigned studies and coordinate statisticians in the program
• Support the Program or Product Statistician in study design, and develop or oversee Statistical Analysis Plans and study-level deliverables
• Give statistical input to protocols, CRFs and TFL shells, and ensure study interpretations and CSRs are scientifically justified
• Provide programming support for reporting, simulations and exploratory analyses, and contribute to CSRs, regulatory responses, publications and abstracts
• For the Program Statistician: contribute to the Clinical Development Plan aligned with TPPs and Target Label, and to regulatory documents such as eCTD, IB, PSUR and RMPT
• Take a proactive role in designing innovative studies and programs, including Go/No Go criteria and risk levels
• Stay up to date with new statistical methods and guidelines through literature and professional events, and help develop SOPs

Required profile

• Bachelor of Science in mathematical statistics, statistics or equivalent; MSc or PhD desired
• Minimum 5 years as a statistician in pharma, CRO or a related field, including study statistician experience
• Experience across more than one phase of clinical development
• Excellent written and oral English

Required skills

• Comprehensive knowledge of clinical and pharmaceutical drug development
• Sound knowledge of theoretical and applied statistics
• Statistical programming in SAS; R or other statistical software desirable
• Good understanding of the regulatory environment and ability to act as the company's statistical representative at regulatory interactions
• Ability to coach less experienced statisticians and to communicate statistics to non-statisticians
• Desired: CDISC (SDTM, ADaM), regulatory submission and defense experience, and clinical program and study design experience