Biostatistical Programming Manager

Role Description

Amgen is seeking a Biostatistical Programming Manager to join the Center for Observational Research (CfOR) organization. This individual will report to the Biostatistical Programming Director of Obesity Programming in CfOR’s Data & Analytic Center.

This role will support the CfOR organization by:

• Setting goals with CfOR epidemiologists.
• Laying out a strategy to deliver on those goals.
• Coordinating with a functional service provider-based team of contract statistical programmers to achieve the goals.
• Staying informed of evolving department needs and industry best practices.
• Identifying innovative, impactful proposals to increase efficiency and support the organization’s growth strategies.

Responsibilities include:

• Leading an FSP-based biostatistical programming team conducting ad hoc studies and analyses delivering on time and to specifications.
• Identifying potential efficiency improvements and proposing solutions.
• Ensuring the analysis and presentation of biomedical data is accurate and complete.
• Adhering to Amgen policies, SOPs, and other controlled documents.
• Reviewing and approving key study-related documents produced by other functions, e.g., SAPs, CRF, Data Management Plan, etc.
• Writing, and/or reviewing and approving programming plans and analytic dataset specifications.
• Representing the programming function and participating in multidisciplinary team meetings.
• Contributing to the continuous improvement of programming, CfOR, and Research and Development (R&D) processes.
• Participating in the development and review of CfOR Policies, SOPs, and other controlled documents.
• Participating in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and responding to audit questions and findings.
• Interviewing potential programming candidates.
• Actively participating in external professional organizations, conferences, and/or meetings.
• Providing input to and participating in intra-departmental and CfOR meetings.
• Supporting and mentoring junior programmers.

Qualifications

• Doctorate degree in Computer Science, Data Science, Statistics, Mathematics, or Life Sciences OR
• Master’s degree and 3 years of experience in Computer Science, Data Science, Statistics, Mathematics, or Life Sciences OR
• Bachelor’s degree and 5 years of experience in Computer Science, Data Science, Statistics, Mathematics, or Life Sciences.
• Demonstrated ability to write, test, and validate software programs and macros in SAS, Databricks, or R to produce analysis datasets and presentation output for regulatory submissions, publications, and other communications.
• Experience with real-world healthcare data such as Flatiron, Ontada, MarketScan, Optum, Medicare, and EMR databases.

Requirements

• Master’s degree in Epidemiology, Biostatistics, or other subject with high statistical content (preferred).
• Vendor relationship management or related experience with functional service providers (preferred).
• Experience in a regulated environment (preferred).
• Pharmaceutical industry experience (preferred).
• Minimum five years SAS statistical programming experience (preferred).
• Database programming using SQL and/or experience with advanced statistical methods such as survival and regression (preferred).

Benefits

• 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, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.

Company Description

Amgen is dedicated to improving the quality of life for people around the world, fostering an inclusive environment of diverse, ethical, committed, and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients.