Senior Biostatistical Programming Manager

Amgen

. Work in Amgen's Biosimilar organization supporting multiple products .

Posted 11/5/2026full-timeRemote • United StatesSenior💰 $151,838 - $205,428 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in statistical programming within clinical development, with advanced skills in SAS and knowledge of CDISC standards. Capable of leading programming teams, ensuring compliance, and contributing to regulatory submissions and process improvements.

Highest-signal resume keywords

Advanced SAS Programming SkillsStatistical Programming ExperienceKnowledge of CDISC StandardsRegulatory Submissions ExperienceProject Management Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

SAS - BASESAS - STATSAS - MacroSAS GraphSQLStatistical AnalysisData Quality ChecksStatistical Analysis PlansDataset SpecificationsProgramming Languages

Soft Skills

Excellent Communication SkillsCross-Functional Team CollaborationLeadership AbilitiesTraining and Mentoring Skills

Tools & Technologies

Pinnacle21CRO Management ToolsDatabase Development ToolsData Management Plans

Industry Keywords

Biosimilar DevelopmentClinical DevelopmentRegulatory ComplianceOperational EfficiencyStatistical Outputs

Tech Stack

Tools & technologies

JavaSQL

About the role

Key responsibilities & impact

Work in Amgen's Biosimilar organization supporting multiple products
Represent the product programming function and participate in multidisciplinary project team meetings
Collaborate closely 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 with CROs
Review and approve analysis dataset specifications
Review or contribute to data management plans, database development, and edit checks plans
Contribute to and review statistical analysis plans and results in IBs, protocols, clinical study reports, integrated summaries, publications, and other documents
Provide support and input in protocol development, case report form design, and data collection
Ensure statistical outputs, datasets, and related documentation are archived according to company standards
Anticipate and communicate resource and quality issues affecting deliverables or timelines
Participate in review of CRO policies, SOPs, and controlled document development
Participate in recruitment of programming staff within the Biosimilar organization
Recommend 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
Adhere to Amgen policies, SOPs, and standards applicable to biosimilar development

Requirements

What you’ll need

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
MSc or higher degree in quantitative or scientific subjects preferred
Familiarity with other programming languages (e.g. Java, 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, e.g., Pinnacle21
Experience of working within a global team and CRO partners to ensure operational excellence and efficiencies
Prior staff development and project management experience
Ability to train others

Benefits

Comp & perks

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible
Career development opportunities
Work/life balance support