Manager / Sr. Manager, Statistical Programming jobs in United States
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Arrowhead Pharmaceuticals · 10 hours ago

Manager / Sr. Manager, Statistical Programming

Arrowhead Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company focused on developing innovative drugs for diseases with a genetic basis. The Manager of Statistical Programming will provide technical leadership and collaborate with various functional teams to support clinical studies and ensure the delivery of high-quality statistical programming outputs.

BiotechnologyHealth CareNanotechnologyPharmaceutical
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Comp. & Benefits
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Responsibilities

Review of analysis plans for appropriate methodologies
Review of clinical data as SDTM dataset
Development of analysis databases (ADaM)
Programming of study analyses and review of study results
Conduct ad-hoc and exploratory statistical analysis and support manuscript preparation
Communicate the project requirements for cleanup and data capture to ensure the key study variables are suitable for analysis
Assist in efforts to identify, develop and implement departmental standards, applications, processes and training; and
Assist in identifying consultants and the selection of service providers and oversees statistical and programming deliverables by CROs or service providers

Qualification

BiostatisticsSASClinical developmentR studioCDISC guidelinesVendor managementCommunication skillsTeam collaboration

Required

Master's degree in Biostatistics/Statistics
4 years of relevant programming experience in pharmaceutical or biotechnology drug development
Proficiency in the use of statistical software including SAS, and familiarity of the use of R studio
Excellent verbal and written communication skills
Effective in communication and team collaboration, influencing across different functional lines
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 programming services of CRO vendors
Knowledge of cross-functional department functions/roles within a drug development company

Preferred

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

Benefits

Competitive salaries
Excellent benefit package

Company

Arrowhead Pharmaceuticals

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Arrowhead Pharmaceuticals is a biotechnology company that focuses on the development of medicine to treat diseases with a genetic origin.

Funding

Current Stage
Public Company
Total Funding
$1.62B
Key Investors
Sarepta TherapeuticsSixth StreetSilence Therapeutics
2024-11-26Post Ipo Equity· $325M
2024-08-08Post Ipo Debt· $400M
2024-01-03Post Ipo Equity· $450M

Leadership Team

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Christopher Anzalone
President and Chief Executive Officer
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Bruce Given
Chief Operating Officer
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Company data provided by crunchbase