Manager, Statistical Programming
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a commercial-stage biopharmaceutical company developing 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 (RNAi) mechanism to induce rapid, deep, and durable knockdown of target genes. RNAi is a natural pathway in living cells that inhibits gene expression, affecting protein production. Arrowhead’s RNAi-based therapeutics leverage this pathway to address diseases with a genetic basis, often characterized by protein overproduction. Our RNAi technologies enable us to target conditions across virtually any therapeutic area, including disease targets not addressable by small molecules and biologics. Arrowhead is leading the field in expanding RNAi applications beyond the liver, with a clinical pipeline targeting liver and lung diseases and a promising preclinical pipeline. Headquartered in Pasadena, CA, Arrowhead has research and development teams in Madison, WI, and San Diego, CA, and a state-of-the-art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators collaborating to bring new therapies to patients in need.
About the role
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 collaborate closely with functional teams, including Clinical Development and Operations, Regulatory, Data Management, Medical Affairs, and Program Management.
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 analysis 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 selecting service providers, and oversee statistical and programming deliverables by CROs or service providers.
Requirements
- Master’s degree in Biostatistics/Statistics.
- 4 years of relevant programming experience in pharmaceutical or biotechnology drug development.
- Proficiency in statistical software, including SAS, and familiarity with R Studio.
- Excellent verbal and written communication skills.
- Effective in cross-functional collaboration and influencing teams.
- Understanding and experience with the clinical development lifecycle, including regulatory submission and post-approval activities.
- Experience interacting with and overseeing programming services of CRO vendors.
- Knowledge of cross-functional department roles within a drug development company.
Preferred Qualifications
- Understanding of regulatory guidelines related to CDISC, SDTM, and ADaM specifications.
Pay
California pay range: $145,000 USD - $160,000 USD.
Benefits
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.