Manager/Sr. Manager, Biostatistics jobs in United States
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Arrowhead Pharmaceuticals · 3 months ago

Manager/Sr. Manager, Biostatistics

Arrowhead Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company focused on developing innovative RNAi-based therapeutics for intractable diseases. They are seeking a biostatistician to provide technical leadership and collaborate with various functional teams to support clinical studies across their expanding portfolio.

BiotechnologyHealth CareNanotechnologyPharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

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
Assist in identifying consultants and the selection of service providers

Qualification

In BiostatisticsSASRClinical development lifecycleCRO vendor oversightStatistical analysis plansRegulatory guidelinesCommunication skillsTeam collaboration

Required

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
Proficiency in the use of statistical software including SAS and R at minimum; familiarity with East and Sportfire
Excellent verbal and written communication skills
Knowledge of pharmaceutical clinical development processes and ability to effectively apply technical principles and methods to clinical drug development
Effective in communication and team collaboration, influencing across different functional lines
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.

H1B Sponsorship

Arrowhead Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (5)
2023 (1)
2022 (5)
2020 (1)

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