Statistical Programming - Analysis & Reporting Programming 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:

• Development and maintenance SOPs, corresponding processes, assuring they are of high quality and compliant with regulatory requirements

• Applies "Quality by Design" (QBD) principles to all BARDS processes and projects

• Development and maintenance of training content, including videos

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

• Drive compliance initiatives, change management and communication

• Partnership in managing, prioritizing, and implementing portfolio projects

• Supports audit and inspections Center of Excellence with audits, inspections and CAPA (Corrective Action and Preventive Action) management

• Engagement with operational staff and partners globally

• Lead and actively contribute to departmental strategic initiative project teams

• Additional responsibilities as delegated by Manager

Education and Minimum Requirement:

BA/BS in Computer Science, Statistics, Applied Mathematics, Pharmacy, Nursing, Information Technology, Life Sciences, Engineering, or related field plus 5-8 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, Pharmacy, Nursing, Information Technology, Life Sciences, Engineering, or related field plus 2-5 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:

• 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.

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

• Demonstrated success in the assurance of deliverable quality and process compliance.

• 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.

• Exceptional people and thought leadership skills, with the ability to think strategically, work independently and influence others.

• SAS or R programming experience

** Preferred Skills and Experience:

• Experience developing and maintaining process documents e.g., SOPs.

• Experience developing and maintaining training content, including videos.

• Experience in process assessment, improvement, and operational excellence

• Experience developing and managing a project plan.

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

• Active in professional societies.

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In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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Expected salary range:

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R230198