Statistician(m/w/x)

Beschreibung

As a Statistician, you will play a vital role in clinical trials, applying statistical expertise to ensure scientific rigor and regulatory compliance. Your day-to-day responsibilities will involve collaborating with study teams, drafting key documents, and analyzing data to support decision-making and regulatory submissions.

Anforderungen

• •MSc or PhD in Statistics, Biostatistics, or related field
• •0-2 years of relevant experience in clinical trial statistics
• •Familiarity with ICH guidelines, GCP, and regulatory requirements
• •Strong understanding of statistical principles and methodology
• •Proficiency in SAS and/or R and familiarity with CDISC standards
• •Capacity for independent thinking and decision-making
• •Excellent strategic agility, problem-solving, and critical thinking skills
• •Respect for cultural differences in a global workplace
• •Excellent verbal and written communication skills
• •Experience working in cross-functional teams
• •Effective communication skills for non-statistical audiences
• •Experience with multiple phases of drug development
• •Ability to influence and translate complex data for non-technical stakeholders
• •Strategic mindset for portfolio-level decisions

Aufgaben

• •Contribute to trial design using standard statistical methods
• •Draft and review protocols, statistical analysis plans (SAPs), and case report forms (CRFs)
• •Perform or support statistical analyses according to SAPs
• •Represent Biostatistics and PDD at the Study Team level
• •Collaborate with study team members to meet deliverables
• •Summarize findings clearly with support from senior colleagues
• •Contribute to CSR development and regulatory responses
• •Apply judgment to address moderately complex statistical or data issues
• •Participate in peer review and mentoring to uphold quality

Tools & Technologien