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 (Senior Associate) 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.
Responsibilities
- Support statistical aspects of clinical trials including input on study design, randomization, sample size calculations, and statistical analysis plans (SAPs)
- Draft and contribute to statistical methods sections of protocols, SAPs, and clinical study reports (CSRs)
- Perform data analyses using SAS and/or R, and assist with interpretation of results
- Collaborate closely with data management and statistical programming teams to ensure high-quality data and analysis outputs
- Participate in the development of summary tables, figures, and listings for regulatory submissions and publications
- Assist in reviewing and QC of statistical outputs and documents
- Support the evaluation of statistical methodologies and explore innovative analytical techniques as needed
- Contribute to departmental process improvements, documentation, and knowledge sharing
Requirements
- PhD in Biostatistics or Statistics
- Hands-on experience with statistical software packages (e.g., SAS and/or R)
- Understanding of clinical trial phases and statistical considerations in clinical research
- Strong attention to detail, organizational skills, and ability to manage multiple tasks
- Effective written and verbal communication skills
- Willingness to learn and take direction while growing into greater independence
Preferred
- 1+ years of relevant experience in the pharmaceutical, biotechnology, or CRO industry, is preferred.
- Familiarity with regulatory guidance and industry standards (e.g., ICH E9, CDISC standards such as SDTM and ADaM)
- Exposure to working with CROs or cross-functional clinical trial teams
- Knowledge of pulmonary function therapeutic area and drug development in this TA
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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Top Skills
Arrowhead Pharmaceuticals Pasadena, California, USA Office
225 South Lake Avenue, Suite 1050, Pasadena, CA, United States, 91101
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