Arrowhead Pharmaceuticals, Inc. Pasadena , CA 91101
Posted 2 months ago
The Position
We are seeking a Sr. Manager or Associate Director 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.
Responsibilities
Manage the statistical programming team
Review of analysis plans for appropriate methodologies
Review of clinical data as SDTM data sets
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 degree in Biostatistics or a related field with a minimum of 5-7 years of relevant programming experience in pharmaceutical or biotechnology drug development
Management experience in statistical programming
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
Preferred:
Arrowhead Pharmaceuticals, Inc.