Principal Statistician, Global Rare Diseases

Tasks

• Collaborate on regulatory documents and eCTD statistical deliverables
• Define randomization procedures
• Develop statistical analysis methods and analyses
• Develop statistical tables figures and data listings
• Interact with CROs for outsourced statistical activities
• Interpret clinical trial data and report results
• Lead statistical activities for Data Review Meetings
• Lead study design and sample size calculation
• Perform statistical analyses for clinical trials
• Plan and conduct post hoc exploratory and regulatory requested analyses
• Provide statistical expertise for drug development programs
• Respond to statistical queries from regulatory agencies
• Review Statistical Analysis Plan and derived data sets
• Review clinical study reports
• Review publications abstracts posters and manuscripts
• Supervise statistical programmers and deliverables
• Support regulatory audits and inspections
• Support regulatory submissions with statistical expertise

Perks/Benefits

• Flexible benefits
• Pension
• Private medical insurance
• Relocation support
• Remote work
• Training resources
• Wellbeing programme
• Work-life balance initiatives

Skills/Tech-stack

Adaptive Design | Analysis Plan | Bayesian Methods | Biostatistics | CDISC | CFR 21.11 | CRO collaboration | Calculation tools | Clinical trials | Data sets | Derived Data | Derived Data Sets | ECTD | Exploratory analysis | GCDMP | GCP | ICH GCP | Patient randomization | Post-hoc analysis | Regulatory Submissions | SAS | Sample Size | Sample Size Calculation | Sample Size Calculation Tools | Statistical Analysis | Statistical Analysis Plan | Statistical methodology | Study design