Amgen Manager, Statistical Programming in Thousand Oaks, California

Amgen is seeking a Statistical Programming Manager to join the Center for Observational Research (CfOR) organization. This individual will report to a Director or Sr. Manager of Statistical 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. Four roles are available (described below).

Available Roles

Therapeutic Area Statistical Programming Manager (2): Lead an FSP-based statistical programming team conducting ad hoc studies and analyses for a set of therapeutic areas (Oncology or non-Oncology).

Descriptive Epidemiology Statistical Programming Manager: Lead an FSP-based statistical programming team developing cohorts, analytic datasets and interactive visualizations to enable functions across Amgen to produce real-world evidence efficiently.

Amgen Sentinel Statistical Programming Manager: Lead an FSP-based statistical programming team in developing analytic tools as part of an advanced methodology workbench, enabling knowledgeable users to conduct complex analytics efficiently using standards. Primarily in support of pharmacovigilance but with broad applications.

Responsibilities

Coordinate with functional leads to prioritize and manage workflow

Manage FSP-based statistical programming team to deliver on time and to specifications

Identify potential efficiency improvements and propose solutions

Collaborate with CfOR FSP liaison to ensure performance and quality standards from FSP-based statistical programming team

Ensure the analysis and presentation of biomedical data is accurate and complete

Adherence to Amgen policies, SOPs and other controlled documents

Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications

Efficiently manage project team resources and timelines

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

Write, and/or review and approve analysis 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)

Write, test and validate department-, product- and protocol-level macros and utilities

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

Basic Qualifications

  • Doctorate degree in Computer Science, Statistics, Mathematics, or Life Sciences

OR

  • Master's degree and 3 years of Computer Science, Statistics, Mathematics, or Life Sciences

OR

  • Bachelor's degree and 5 years of Computer Science, Statistics, Mathematics, or Life Sciences

Preferred Qualifications

  • Master's degree in Epidemiology, Biostatistics, Computer Science, or other subject with high statistical content

  • Vendor relationship management or related experience with functional service providers

  • Experience in a regulated environment

  • Training or experience using the Observational Medical Outcomes Partnership ( OMOP ) common data model

  • Training or experience with the Hadoop database platform and Impala or Hive SQL

  • Pharmaceutical industry experience

  • Minimum five years SAS statistical programming experience

  • Database programming using SQL or experience with advanced statistical methods such as survival and regression

  • Experience with real world healthcare data such as MarketScan, Optum, DRG, PharMetrics, Medicare and EMR databases

Key Competencies

  • Computer programming with SAS, R, Python or other procedural languages

  • Agile project management methodology

  • Understanding of computer operating systems, including cloud-based (AWS), Databricks and UNIX

  • Technical excellence

  • Leadership

  • Innovation

  • Project management

  • Teamwork

  • Problem solving

  • Attention to detail

  • Oral and written communication

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

We are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules - and we need top talent to ensure these molecules become medicines and realize their potential for helping patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.