Biostatistical Programming Manager

Amgen • Boston, MA

17h

About The Position

Join Amgen’s Mission of Serving Patients. Amgen is seeking an 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, and coordinating with a functional service provider-based team of contract statistical programmers to achieve the goals. In addition, the Manager is responsible for staying informed of evolving department needs and industry best practices, looking to identify innovative, impactful proposals to increase efficiency and support the organization’s growth strategies.

Requirements

• Doctorate degree in Computer Science, Data Science, Statistics, Mathematics, or Life Sciences OR Master’s degree and 3 years of Computer Science, Data Science, Statistics, Mathematics, or Life Sciences OR Bachelor’s degree and 5 years of 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, to be included in reports for submission to regulatory agencies, publications and other communications
• Experience with real world healthcare data such as Flatiron, Ontada, MarketScan, Optum, Medicare and EMR databases

Nice To Haves

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

Responsibilities

• Lead an FSP-based biostatistical programming team conducting ad hoc studies and analyses delivering on time and to specifications
• Identify potential efficiency improvements and propose solutions
• Ensure the analysis and presentation of biomedical data is accurate and complete
• Adhere to Amgen policies, SOPs, and other controlled documents
• Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc.
• Write, and/or review and approve programming plans and analytic dataset specifications
• Represent the programming function and participate in multidisciplinary team meetings
• Contribute to the continuous improvement of programming, CfOR, and Research and Development (R&D) processes
• Participate in the development and review of CfOR Policies, SOPs and other controlled documents
• Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings
• Interview potential programming candidates
• Actively participate in external professional organizations, conferences and/or meetings
• Provide input to and participate in intra-departmental and CfOR meetings
• Support and mentor junior programmers

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager