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We are seeking a Manager of statistical programming to join our rapidly growing biometrics team to support clinical studies across Arrowhead’s expanding portfolio. As an internal expert in statistical programming, you will provide technical leadership and statistical programming input to closely collaborate with other functional teams at Arrowhead, including Clinical Development and Operations, Regulatory, Data Management, Medical Affairs, Program Management and others.
Job Responsibility:
Review of analysis plans for appropriate methodologies
Review of clinical data as SDTM dataset
Development of analysis databases (ADaM)
Programming of study analyses and review of study results
Conduct ad-hoc and exploratory statistical analysis and support manuscript preparation
Communicate the project requirements for cleanup and data capture to ensure the key study variables are suitable for analysis
Assist in efforts to identify, develop and implement departmental standards, applications, processes and training
Assist in identifying consultants and the selection of service providers and oversees statistical and programming deliverables by CROs or service providers
Requirements:
Master’s degree in Biostatistics/Statistics
4 years of relevant programming experience in pharmaceutical or biotechnology drug development
Proficiency in the use of statistical software including SAS, and familiarity of the use of R studio
Excellent verbal and written communication skills
Effective in communication and team collaboration, influencing across different functional lines
Understanding and experience with various aspects of a clinical development life-cycle, leading up to regulatory submission and post -approval activities
Experience interacting with and overseeing programming services of CRO vendors
Knowledge of cross-functional department functions/roles within a drug development company
Nice to have:
Understanding of regulatory guidelines related to submission of datasets using CDISC, development of SDTM and ADaM specifications
What we offer:
competitive salaries and an excellent benefit package