TASKS AND RESPONSIBILITIES
• Create or contribute to statistical analysis plans, study/integrated TLF, and ADS specs
• Responsible for leading statistical programming and validation activities for all clinical study requests in close collaboration with study statistical teams
• Prepare statistical programming deliverables for submissions, HEOR, marketing and other functions within the organization
• Responsible for strong partnering with project/compound/integrated statisticians and statistical programming teams to ensure use of compound/project standards
• Responsible for cross-communication with other clinical information & analytics team members ensuring consistency within study standards and definitions
• Ensure compliance with end to end process within a clinical study
• Lead the clinical information & analytics study execution team and/or study statistical analyst team
REQUIREMENTS
• University degree in statistics, mathematics, computer science, natural sciences, informatics or related field or equivalent education
• Several years of experience in statistical programming or statistics in the pharmaceutical or biotechnology industry (Focus CS: PK/PD knowledge preferred)
• Deep project knowledge, including indication relevant issues (oncology experience is preferred)
• Strong MS Office skills and data analysis knowledge
• Excellent demonstrated interpersonal, presentation and communication skills
• Ability to support change in complex organizations
• Fluent English skills, both written and spoken