Manager/Sr. Manager, Biostatistics

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. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position 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 to closely collaborate with other functional teams at Arrowhead, including Clinical Development and Operations, Regulatory, Commercial, Program Management and others.ResponsibilitiesProvide 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 publicationsPartner with cross functional teams to provide strategic biostatistics input to support entire drug development process; ensure statistical integrity of all key deliverablesProvide statistically sound scientific methodology for study design and data analysis input to meet project objectives in accordance to regulatory guidance and industry standardsCollaborate with the programming and data management functions to ensure appropriate data collection and reportingProvide leadership in evaluating alternative or innovative methods of study design and analysisAssist in efforts to identify, develop and implement departmental standards, applications, processes and trainingOversees statistical and programming deliverables by CROsAssist in identifying consultants and the selection of service providersRequirements: PhD in Biostatistics/Statistics5 years of relevant experience in pharmaceutical or biotechnology drug developmentUnderstanding and experience with various aspects of a clinical development life-cycle, leading up to regulatory submission and post-approval activitiesExperience interacting with and overseeing biometrics services of CRO vendorsProficiency in the use of statistical software including SAS and R at minimum; familiarity with East and SportfireExcellent verbal and written communication skillsKnowledge of pharmaceutical clinical development processes and ability to effectively apply technical principles and methods to clinical drug developmentEffective in communication and team collaboration, influencing across different functional linesKnowledge of cross-functional department functions/roles within a drug development companyPreferred:Understanding of regulatory guidelines related to submission of datasets using CDISC, development of SDTM and ADaM specificationsCalifornia pay range $145,000—$190,000 USDArrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy