Senior Biostatistical Programming Leader – Biosimilars

Amgen Inc.; Thousand Oaks (CA); Híbrido; USD 152.000 - 205.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Comprehensive benefits package

Discretionary annual bonus program

Stock-based long-term incentives

Flexible work models

Descripción de la vacante

Amgen Inc. in Thousand Oaks, CA is seeking a Biostatistical Programming Sr Mgr to lead statistical programming for biosimilar development. You will coordinate dataset specifications, review analysis plans, and collaborate with CROs and cross-functional teams to ensure timely submission packages.

The role emphasizes mentoring staff, protocol development support, and delivering high-quality analyses across studies, with opportunities for professional growth and a comprehensive benefits package.

Formación

• BA/BSc or higher degree in quantitative or scientific subjects.
• At least 8 years of relevant statistical programming experience in a clinical development environment.
• Excellent oral and written English communication skills.
• Experience working effectively in a cross-functional team environment.
• Advanced SAS programming skills in processing clinical data (SAS - BASE, STAT, Macro and Graph).
• Working knowledge of latest CDISC SDTM, ADaM and Define-XML standards.
• Ability to lead and manage programmers in the successful and timely completion of all programming activities for a project.
• Ability to effectively perform complex statistical programming and related tasks.

Responsabilidades

• Lead and/or contribute to the statistical analysis plans and results for clinical studies.
• Coordinate and oversee development of dataset specifications and implementation of tables, listings, and figures with CRO partners.
• Review and approve analysis dataset specifications and SDTM/ADaM datasets.
• Support protocol development, case report form design, and data collection.
• Ensure archival of statistical outputs and documentation per company standards.
• Collaborate with Biosimilar Statisticians and cross-functional teams.

Conocimientos

Advanced SAS

CDISC SDTM/ADaM/Define-XML

Statistical programming

Cross-functional collaboration

Java/R programming

Educación

BA/BSc or higher in quantitative/scientific subjects

MSc or higher preferred

Herramientas

SAS Graph

SAS STAT

SAS Macro

SQL

Descripción del empleo

Amgen Inc. in Thousand Oaks, CA is seeking a Biostatistical Programming Sr Mgr to lead statistical programming for biosimilar development. You will coordinate dataset specifications, review analysis plans, and collaborate with CROs and cross-functional teams to ensure timely submission packages.

The role emphasizes mentoring staff, protocol development support, and delivering high-quality analyses across studies, with opportunities for professional growth and a comprehensive benefits package.