Senior Scientist, Statistical Programming

MSD • Rahway, NJ

5d • Hybrid

About The Position

Senior Scientist, Statistical Programming – Rahway, NJ: Support the centralized management of technology, platforms, inspections, and related process and training for the global Statistical Programming organization to ensure it operates in compliance with departmental and company SOPs, regulatory requirements, and standards. Support the Business System Ownership (BSO) of platforms or applications and corresponding documents and training. Work in partnership in managing, prioritizing, and implementing portfolio projects. Drive compliance initiatives, change management and communication. Support audit and inspections Center of Excellence with audits, inspections and CAPA (Corrective Action and Preventive Action) management. Engage with operational staff and partners globally. Lead and actively contribute to departmental strategic initiative project teams. Maintain SOPs, corresponding processes, assuring they are of high quality and complaint with regulatory requirements.

Requirements

• Master’s degree in Computer Science, Statistics, Applied Mathematics, Information Technology, Life Sciences, Engineering, or related field plus at least 2 years in a clinical trial environment (Analysis & Reporting, Information Technology, Data Management etc.) in the pharmaceutical industry, and at least 3 years SAS or R programming experience OR Bachelor’s degree in Computer Science, Statistics, Applied Mathematics, Information Technology, Life Sciences, Engineering, or related field plus at least 5 years in a clinical trial environment (Analysis & Reporting, Information Technology (IT), Data Management etc.) in the pharmaceutical industry, and at least 3 years SAS or R programming experience.
• Must have Business Analyst (BA) experience.
• Must possess 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; and broad knowledge of clinical trials processes, data structures and corresponding tools used to manage, extract, analyze & report data.
• 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; and demonstrated success in the assurance of deliverable quality and process compliance also required.
• Must possess effective interpersonal skills and ability to negotiate and collaborate effectively
• Written, oral, and presentation skills
• Knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
• Must be a project leader
• Possess the ability to complete tasks independently at a project level
• The ability to collaborate with key stakeholders.

Responsibilities

• Support the centralized management of technology, platforms, inspections, and related process and training for the global Statistical Programming organization to ensure it operates in compliance with departmental and company SOPs, regulatory requirements, and standards.
• Support the Business System Ownership (BSO) of platforms or applications and corresponding documents and training.
• Work in partnership in managing, prioritizing, and implementing portfolio projects.
• Drive compliance initiatives, change management and communication.
• Support audit and inspections Center of Excellence with audits, inspections and CAPA (Corrective Action and Preventive Action) management.
• Engage with operational staff and partners globally.
• Lead and actively contribute to departmental strategic initiative project teams.
• Maintain SOPs, corresponding processes, assuring they are of high quality and complaint with regulatory requirements.

Benefits

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits.
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

What This Job Offers

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