Arrowhead Pharmaceuticals is seeking a biostatistician to provide technical leadership and biostatistical input to support clinical studies across their expanding portfolio, ensuring the statistical integrity of all key deliverables in the drug development process.
Requirements
- Proficiency in the use of statistical software including SAS and R at minimum; familiarity with East and Sportfire
- Understanding of regulatory guidelines related to submission of datasets using CDISC, development of SDTM and ADaM specifications
Responsibilities
- Provide sound statistical and operational input, including study and program design, writing of the 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 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 to 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
Other
- 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
- Excellent verbal and written communication skills
