Manager​/Sr. Manager, Biostatistics

Overview

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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’s RNAi-based therapeutics leverage this natural pathway of gene silencing to address diseases with a genetic basis and potentially target targets not addressable by small molecules and biologics. Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a manufacturing facility in Verona, WI.

We are seeking a stellar biostatistician to join our rapidly growing biometrics team to support clinical studies across Arrowhead’s expanding portfolio. As an internal expert in biostatistics, you will provide technical leadership and biostatistical input while collaborating with Clinical Development and Operations, Regulatory, Commercial, Program Management and other functions.

• Provide sound statistical and operational input, including study and program design, writing of protocol sections, statistical analysis plans (SAP), clinical study reports (CSR), regulatory documents or scientific publications
• Partner with cross functional teams to provide strategic biostatistics input to support the entire drug development process; ensure statistical integrity of all key deliverables
• Provide statistically sound scientific methodology for study design and data analysis input to meet project objectives in accordance with regulatory guidance and industry standards
• Collaborate with the programming and data management functions to ensure appropriate data collection and reporting
• Provide leadership in evaluating alternative or innovative methods of study design and analysis
• Assist in efforts to identify, develop and implement departmental standards, applications, processes and training
• Oversees statistical and programming deliverables by CROs
• Assist in identifying consultants and the selection of service providers

• PhD in Biostatistics or a related field
• 5 years of relevant experience in pharmaceutical or biotechnology drug development
• 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 biometrics services of CRO vendors
• Proficiency in the use of statistical software including SAS and R at minimum; familiarity with East and Sportfire
• Excellent verbal and written communication skills
• Knowledge of pharmaceutical clinical development processes and ability to effectively apply technical principles and methods to clinical drug development
• Effective in communication and team collaboration, influencing across different functional lines
• Knowledge of cross-functional department functions/roles within a drug development company

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

California pay range
California pay range

California pay range

$140,000—$160,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

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

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• Mid-Senior level

• Full-time

• Research, Analyst, and Information Technology