Job Details

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Arrowhead focuses on RNA interference (RNAi) therapies and has a pipeline in liver and lung targets with preclinical development in other areas. The corporate headquarters are in Pasadena, CA, with research and development teams in Madison, WI and San Diego, CA, and a manufacturing facility in Verona, WI. Arrowhead's employees are collaborative, science-driven innovators advancing new therapies for patients in need.

The Position

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.

Responsibilities

• Review analysis plans for appropriate methodologies.
• Review clinical data as SDTM datasets.
• Develop analysis databases (ADaM).
• Program study analyses and review study results.
• Conduct ad-hoc and exploratory statistical analyses and support manuscript preparation.
• Communicate project requirements for data cleanup and capture to ensure key study variables are suitable for analysis.
• Assist in identifying, developing and implementing departmental standards, applications, processes and training.
• Assist in identifying consultants and the selection of service providers and oversee statistical and programming deliverables by CROs or service providers.

Requirements

• Master's degree in Biostatistics or a related field.
• 4 years of relevant programming experience in pharmaceutical or biotechnology drug development.
• Proficiency in statistical software including SAS; familiarity with R Studio.
• Excellent verbal and written communication skills; effective in collaboration across functional lines.
• Understanding and experience with various aspects of the clinical development life-cycle, leading up to regulatory submission and post-approval activities.
• Experience 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, including SDTM and ADaM specifications.

California pay range
$145,000—$165,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.