Biostatistical Programming Sr Mgr

Amgen•Thousand Oaks, CA

About The Position

The Biostatistical Programming Sr Mgr works in Amgen’s Biosimilar organization, supporting multiple products. The role represents the product programming function on multidisciplinary project teams and collaborates closely with Biosimilar statisticians and other functional team members. In partnership with CROs in a full-service CRO model, the position coordinates and oversees development of dataset specifications and implementation of tables, listings, and graphs (TLGs) according to statistical analysis plans, work practices, and project timelines. The position reviews and approves analysis dataset specifications; contributes to and reviews data management plans, database development and edit-check plans, statistical analysis plans, and results presented in clinical and regulatory documents. It also supports protocol development, case report form design, data collection, submission data packages, and technical solutions for executing CRO programs on Amgen systems. The role helps ensure outputs, datasets, and documentation are archived according to company standards, anticipates and communicates resource or quality issues, contributes to operational improvement and submission readiness, and participates in recruitment and staff development activities. The position adheres to applicable Amgen policies, SOPs, and standards for biosimilar development.

Requirements

BA/BSc or higher degree in a quantitative or scientific subject.
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 for processing clinical data, including SAS Base, STAT, Macro, and Graph.
Working knowledge of current CDISC SDTM, ADaM, and Define-XML standards.
Ability to lead and manage programmers to complete project programming activities successfully and on time.
Ability to perform complex statistical programming and related tasks.

Nice To Haves

MSc or higher degree in a quantitative or scientific subject.
Familiarity with other programming languages, such as Java or R.
In-depth knowledge of SAS Graph, SAS STAT, SAS Macro, and SQL.
Regulatory submissions experience.
Thorough understanding of and experience with data quality and compliance checks, such as Pinnacle 21.
Experience working with global teams and CRO partners to ensure operational excellence and efficiency.
Prior staff development and project management experience.
Ability to train others.

Responsibilities

Represent the product programming function and participate in multidisciplinary project team meetings.
Collaborate with Biosimilar statisticians and other functional team members.
Coordinate and oversee development of dataset specifications and implementation of TLGs in partnership with CROs, according to statistical analysis plans, work practices, and project timelines.
Review and approve analysis dataset specifications.
Review or contribute to data management plans, database development, and edit-check plans.
Contribute to and review statistical analysis plans and results for investigator brochures, protocols, clinical study reports, integrated summaries of safety and efficacy, publications, and other documents as required.
Support and provide input on protocol development, case report form design, and data collection.
Ensure statistical outputs, datasets, and related documentation are archived clearly, in an organized manner, and on time according to company standards.
Anticipate and communicate resource and quality issues that could affect deliverables or timelines within the functional area or across functions.
Participate in reviewing CRO policies, SOPs, and other controlled documents.
Participate in recruiting programming staff within the Biosimilar organization.
Support operational effectiveness, program-level consistency, and submission readiness, including data standards.
Work with CRO and Amgen teams to assemble submission data packages.
Lead or contribute to technical solutions for executing CRO programs on Amgen systems and perform ad hoc analyses to support submissions and publications.
Lead or contribute to process improvement and operational efficiency.
Follow applicable Amgen policies, SOPs, and other standards for biosimilar development.