Job Description

Manager / Sr. Manager, Biostatistics

Location: Pasadena, CA or San Diego, CA| Onsite

Full Time/Perm role

Must have a PHD in either Biostatistics or Statistics

Must have 5+ years in Clinical development biostatistics in drug development (not medical device).

The Position

We are seeking a stellar biostatistician to join our rapidly growing biometrics team to support clinical studies across our expanding portfolio. As an internal expert in biostatistics, you will provide technical leadership and biostatistical input to closely collaborate with other functional teams, including Clinical Development and Operations, Regulatory, Commercial, Program Management and others.

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

Requirements:

• 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

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