Sr. Manager/Associate Director, Statistical Programming

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:

• Understanding of regulatory guidelines related to submission of datasets using CDISC, development of SDTM and ADaM specifications