Scientist, Clinical Schedule Manager, Statistical Programming (Hybrid) Full-time

Clinical Schedule Manager

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.

Clinical Schedule Managers have a key role in our clinical trials and support all therapeutic areas and every phase of drug development across Research & Development.

This position contributes to the overall management of clinical schedules in support of clinical study randomization and data unblinding under the guidance of a more experienced staff member. The clinical schedule manager will collaborate with biostatisticians within BARDS, as well as members of data management, clinical supplies, and clinical operations to develop requirements for randomization and trial supply management systems.

Primary Activities:

• Contribute to clinical schedule design, generation, review, and distribution
• Ensure compliance for maintaining blinding during study conduct
• Perform activities related to the support of unblinding for data analysis
• Assure high quality and timely deliverables
• Communicate and collaborate effectively with operational staff and partners globally

Qualifications

Education and Minimum Requirement:

• BA/BS in Computer or Data Science, Statistics, Life Sciences, or related field with a minimum of 2 years of pharmaceutical drug development experience
• or MS in Computer or Data Science, Statistics, Life Sciences, or related field

Skills and Experience:

• Working knowledge of the clinical development process and clinical study design
• Basic understanding of statistics, clinical, medical monitoring, and data management concepts
• Good understanding of clinical trial randomization, blinding, and unblinding processes and tools
• Ability to organize, prioritize, and work efficiently and effectively in a constantly changing environment
• Ability to collaborate effectively with others on a team, take direction effectively, function independently, and complete tasks on time
• Written, oral, and presentation skills
• Motivated to advance career by investing in development activities and taking on responsibilities with increasing levels of challenge
• Knowledge of standard operating procedures and software development life cycle
• Knowledge in development of Analysis and Reporting deliverables for Research & Development projects
• Experience reviewing, writing, editing, and maintaining documentation
• Prior experience in developing AI agents and workflows is preferred

Required Skills:

Clinical Trials, Communication, Detail-Oriented, Stakeholder Relationship Management, Statistics, Teamwork

Preferred Skills:

AI Agents, Artificial Intelligence (AI), Confidential Data Handling

Salary Range for this role is $96,200.00 – $151,400.00