Biostatistical Programming Sr Mgr

Amgen•Thousand Oaks, CA

6d•$151,838 - $205,428

About The Position

The Biostatistical Programming Sr Mgr works in Amgen’s Biosimilar organization, supporting multiple products and representing the product programming function on multidisciplinary project teams. The role partners closely with Biosimilar statisticians, other functional team members, and CROs in a full-service CRO model to oversee programming deliverables, including dataset specifications and tables, listings, and graphs (TLGs), in accordance with statistical analysis plans, work practices, and project timelines. The position contributes to analysis planning, data management, protocol and case report form development, clinical data collection, regulatory and scientific documents, submission data packages, and publication support. It also provides technical solutions for executing CRO programs on Amgen systems, supports ad hoc analyses, promotes submission readiness and consistency in data standards, and advances process improvement and operational efficiency. The role monitors resources, quality, and timelines; supports CRO document and policy review; and may participate in recruiting and developing programming staff. The position requires adherence to Amgen policies, SOPs, and applicable biosimilar development standards.

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 all project programming activities successfully and on time.
Ability to perform complex statistical programming and related tasks effectively.

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 and experience with data quality and compliance checks, such as Pinnacle21.
Experience working with a global team and CRO partners to ensure operational excellence and efficiencies.
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 according to statistical analysis plans, work practices, and project timelines, in partnership with CROs.
Review and approve analysis dataset specifications.
Contribute to or review data management plans, database development, and edit-check plans.
Contribute to and review statistical analysis plans and results presented in investigator brochures, protocols, clinical study reports, integrated summaries of safety and efficacy, publications, and other documents.
Provide support and input for protocol development, case report form design, and data collection.
Ensure statistical outputs, datasets, and related documentation are archived clearly, in an organized and timely manner, according to company standards.
Anticipate and communicate resource and quality issues that may affect deliverables or timelines within the functional area and cross-functionally.
Participate in review of CRO policies, SOPs, and other controlled-document development.
Participate in recruitment of programming staff within the Biosimilar organization.
Promote 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 supporting submissions and publications.
Lead or contribute to process improvement and operational efficiency.
Follow Amgen policies, SOPs, and other standards applicable to biosimilar development.