Senior Biostatistical Programming Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Contribute to Amgen's Biosimilar organization by supporting various products.

• Act as a representative for the product programming function and engage in multidisciplinary project team meetings.

• Collaborate extensively with Biosimilar Statisticians and other team members across functions.

• Manage and oversee the creation of dataset specifications and the implementation of TLGs in accordance with statistical analysis plans, project timelines, and work practices with CROs.

• Review and approve analysis dataset specifications.

• Review or contribute to data management plans, database creation, and edit checks plans.

• Contribute to and review statistical analysis plans and results in IBs, protocols, clinical study reports, integrated summaries, publications, and various other documents.

• Provide support and insights in protocol development, case report form design, and data collection.

• Ensure that statistical outputs, datasets, and associated documentation are archived according to company standards.

• Proactively identify and communicate resource and quality issues that may impact deliverables or timelines.

• Participate in the evaluation of CRO policies, SOPs, and the development of controlled documents.

• Engage in the recruitment of programming staff within the Biosimilar organization.

• Suggest program-level consistency and ensure submission readiness, including adherence to data standards.

• Collaborate with CRO and Amgen teams to compile submission data packages.

• Lead or assist in formulating technical solutions for executing CRO programs on Amgen systems and conduct ad-hoc analyses supporting submissions and publications.

• Drive or contribute to process enhancement and operational efficiency initiatives.

• Comply with Amgen policies, SOPs, and standards relevant to biosimilar development.

⛳️ Requirements

• A BA/BSc or higher degree in quantitative or scientific disciplines.

• A minimum of 8 years of pertinent statistical programming experience in a clinical development setting.

• Exceptional oral and written communication skills in English.

• Proven ability to work effectively within a cross-functional team environment.

• Advanced proficiency in SAS programming for processing clinical data (SAS - BASE, STAT, Macro, and Graph).

• Familiarity with the latest CDISC SDTM, ADaM, and Define-XML standards.

• Capability to lead and manage programmers to ensure successful and timely completion of all programming tasks for a project.

• Proficiency in performing complex statistical programming and related activities effectively.

• An MSc or higher degree in quantitative or scientific fields is preferred.

• Knowledge of additional programming languages (e.g., Java, R) is a plus.

• Extensive knowledge of SAS Graph, SAS STAT, SAS Macro, and SQL.

• Experience in regulatory submissions.

• Comprehensive understanding and experience with data quality and compliance checks, such as Pinnacle21.

• Experience collaborating with global teams and CRO partners to achieve operational excellence and efficiency.

• Previous experience in staff development and project management.

• Ability to provide training to others.

🏝️ Benefits

• A comprehensive employee benefits package that includes a Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision insurance coverage.

• Life and disability insurance options.

• Flexible spending accounts available.

• Participation in a discretionary annual bonus program.

• Stock-based long-term incentive programs.

• Award-winning time-off plans.

• Flexible work models where feasible.

• Opportunities for career development.

• Support for work/life balance.