Associate Principal Scientist, Statistical Programming A&R Platforms and Systems (Hybrid)

Job Description

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

Responsibilities:

This position supports the centralized management of technology, platforms, inspections, and related process and training for the global Statistical Programming organization. The individual supports the organization to ensure it operates in compliance with departmental and company SOPs, regulatory requirements, and standards.

Primary Activities:

• Business System Ownership (BSO) of platforms or applications and corresponding documents and training

• Drive compliance initiatives, change management and communication across multiple audiences.

• Partnership in managing, prioritizing, and implementing portfolio projects.

• Engagement with operational staff and partners globally.

• Lead and actively contribute to departmental strategic initiative project teams.

• Creation and maintenance of SAS/R tools used to generate metrics.

Education and Minimum Requirements:

BA/BS in Computer Science, Statistics, Applied Mathematics, Information Technology, Life Sciences, Engineering, or related field plus 9-12 years in a clinical trial environment (Analysis & Reporting, Information Technology, Data Management etc.) in the pharmaceutical industry, and 3-5 years SAS or R programming experience.

MS in Computer Science, Statistics, Applied Mathematics, Information Technology, Life Sciences, Engineering, or related field plus 6-9 years in a clinical trial environment (Analysis & Reporting, Information Technology, Data Management etc.) in the pharmaceutical industry, and 3-5 years SAS or R programming experience.

Department Required Skills and Experience:

• Effective interpersonal skills and ability to negotiate and collaborate effectively.

• Effective written, oral, and presentation skills

• Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)

• A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders.

Position Specific Required Skills and Experience:

• Experience gathering system user stories and documenting system requirements.

• Experience authoring test cases and data sheets and executing test cases in ALM.

• Broad knowledge of clinical trials processes, data structures and corresponding tools used to manage, extract, analyze & report data.

• Comprehensive knowledge of reporting processes (SOPs) that align with regulatory requirements (e.g., 21 CFR Part 11, ICH GCPs) and software development life cycle (SDLC)

• Understanding of Statistical, Clinical, Medical Monitoring and Data Management concepts as applied to drug/vaccine development within the pharmaceutical industry.

• Ability to anticipate stakeholder requirements; focus on customers; ability to listen to and address stakeholders’ needs and concerns.

• Ability and interest to work across cultures and geographies including partnering with statistical programming staff in AP and EU regions and offshore programming resources.

• Demonstrated ability to communicate effectively across multiple audiences and clearly explain processes and system functionality to users.

• SAS or R programming experience

** Preferred Skills and Experience:

• Experience as a BSO for Good Clinical Practices (GCP) systems

• Experience with SDLC, ALM, SAS, R, Jira, Confluence, Agile, Digital SDLC

• Experience developing and maintaining systems training content, including videos.

• Experience in process assessment, improvement, and operational excellence

• Active in professional societies.

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We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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Requisition ID:R230206