Director, Statistical Programming, Clinical Schedules

MSD

. Direct clinical schedule managers developing and reviewing randomization and component ID schedules and related documents for drug and vaccine programs across early- and late-phase development .

Posted 9/25/2026full-timeUnited StatesLead💰 $190,800 - $300,300 per yearWebsite

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

Direct clinical schedule managers developing and reviewing randomization and component ID schedules and related documents for drug and vaccine programs across early- and late-phase development
Support provisioning for unblinded analyses
Collaborate with Statistics, Data Management, IT, Statistical Programming, Clinical Safety, IVRS & PRO Services, and Global Clinical Supply colleagues
Evolve clinical schedule management, study blinding and unblinding capabilities, packaging designs, and data collection practices
Set direction for clinical schedule management across therapeutic areas
Ensure schedule creation and unblinding preparation are efficient, timely, high quality, and compliant
Manage staff resources and forecast support based on the book of business
Ensure consistent application of SOPs, standards, quality, and compliance measures
Identify improvements and solve business challenges with cross-functional stakeholders
Establish partnerships with statistical and statistical programming stakeholders in BARDS LDS and EDS
Provide technical guidance to employees and colleagues
Engage with operational staff and partners globally
Build and foster group capability for project delivery
Hire qualified staff
Complete performance and employee development, including coaching and mentoring
Manage clinical schedule manager training plans
Lead and contribute to departmental strategic initiatives
Represent Clinical Schedule Management at leadership level as a visible contributor and decision maker

Requirements

What you’ll need

Bachelor's degree or Master's degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biological Sciences, or Engineering; Master's degree is preferred
BS plus a minimum of 12 years or MS with a minimum of 10 years working in an analysis and reporting environment
2 years of statistical programming experience in a clinical trial environment
1 year of experience as a people manager leading a team
7 years of project management experience in the development and execution of statistical analysis and reporting deliverables
Prior people management experience with demonstrated ability to lead and develop people
Expertise managing and forecasting team resources at the project and therapeutic area level
Broad knowledge and demonstrated experience developing clinical schedule management deliverables according to quality, compliance, and timeliness requirements
Expertise in randomization, clinical schedule specification, and intersection with IRT and clinical supplies
US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level, including development of submission deliverables
Deep understanding of Late-Stage Development and Early-Stage Development business needs and regulatory requirements
Knowledge of regulatory agency requirements pertaining to maintaining study blind and clinical schedule management
Excellent communication and negotiation skills with demonstrated teamwork and collaboration
Ability to engage key stakeholders, handle change, and assimilate to new projects and stakeholders
Demonstrated success assuring deliverable quality and process compliance
Strong working knowledge of reporting processes, SOPs, and software development life cycle (SDLC)
Experience leading programming teams including functional sourcing partners, domestic contractors, and global resources
Ability and interest to work across cultures and geographies
Preferred: 3+ years managing a team of clinical schedule managers
Preferred: change management, process improvement, strategic and departmental initiative leadership, statistical analysis methods, clinical data management concepts, stakeholder and regulatory requirements, professional societies

Benefits

Comp & perks

Annual bonus
Long-term incentive, if applicable
Medical, dental, and vision healthcare
Other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate days
Sick days
Hybrid work arrangement
Visa sponsorship