Director, Statistical Programming, Clinical Schedules (Hybrid)

Merck; Rahway (NJ); Hybrid; USD 191,000 - 300,000; Full time

Job summary

Merck in Rahway, NJ (or Upper Gwynedd, PA) is seeking a senior leader to direct Clinical Schedule Management for drug and vaccine programs across early and late phase development.

From coordinating cross-functional teams to optimize unblinding processes, you will drive strategic initiatives, staff development, and resource forecasting to ensure high-quality deliverables.

Qualifications

• BS or MS with extensive experience in an analysis and reporting environment.
• Experience leading a programming team with cross-functional partners is preferred.
• Strong communication and stakeholder management skills are essential.

Responsibilities

• Direct the activities of clinical schedule managers across drug and vaccine programs in early and late phases.
• Collaborate with Statistics, Data Management, IT, and Global Clinical Supply to evolve schedule management and unblinding capabilities.
• Set direction for clinical schedule management across therapeutic areas ensuring efficiency and quality.
• Manage staff resources, forecast support, and ensure SOPs, standards, and compliance are applied consistently.
• Engage with stakeholders to identify improvements and partner with statistical teams BARDS LDS, EDS.
• Provide technical guidance and mentor employees; lead departmental strategic initiatives.
• Represent Clinical Schedule Management at leadership levels and drive decision making.

Skills

Functional Strategy

Item Response Theory (IRT)

Organizational Leadership

People Management

Program Delivery Management

Program Management

Stakeholder Relationship Management

Statistical Analysis

Strategic Planning

Strategic Thinking

Strategy Deployment

Strategy Development

Education

Bachelor's or Master's degree in Computer Science, Statistics, Applied Mathematics, Biological Sciences, or Engineering

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.

This position may be based in either Rahway, NJ or Upper Gwynedd, PA.

Primary Responsibilities

• Direct the activities of clinical schedule managers whose predominant activities are the development and review of randomization and component ID schedules and associated documents and specifications for drug and vaccine programs across early and late phase drug development and the support related to provisioning for unblinded analyses
• Interact with cross functional our research lab division colleagues including, Statistics, Data Management, IT, Statistical Programming, Clinical Safety, IVRS & PRO Services, and Global Clinical Supply to evolve clinical schedule management, study blinding and unblinding capabilities to proactively address new trial designs and complexities, new study medication packaging designs, and data collection practices.
• Set the direction for clinical schedule management across all therapeutic areas for early and late phase clinical development, ensuring that schedule creation and unblinding preparation are executed efficiently, timely, and with high quality
• Manage staff resources and forecast support based on the book of business.
• Ensure appropriate and consistent application of SOPs, standards and quality and compliance measures
• Engage with cross functional stakeholders to identify areas for improvement and to solve business challenges. Establish strong partnerships with statistical and statistical programming stakeholders in BARDS LDS, EDS
• Provide technical guidance to employees and colleagues
• Engage with operational staff and partners globally
• Contribute to building and fostering group capability for the delivery of expertise, and behaviors required to deliver success on projects
• Hire appropriate, qualified staff
• Complete performance and employee development including coaching and mentoring
• Manage CSM training plans
• Lead and actively contribute to departmental strategic initiatives
• Represent Clinical Schedule Management at a leadership level. Be a visible contributor and decision maker.

Education

• Bachelors or Master's (preferred) Degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biological Sciences, or Engineering

Required Experience

• BS plus a minimum of 12 years or MS with a minimum of 10 years working in an analysis and reporting environment.
• 2 years statistical programing 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’s resources at the project and therapeutic area level
• Broad knowledge and demonstrated experience in 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 the development of submission deliverables
• A deep understanding of both 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 a demonstrated history of teamwork and collaboration; deals well with change and seamlessly assimilates to new projects and stakeholders; ability to engage key stakeholders
• Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life cycle (SDLC)
• Experience leading the activities of a programming team that includes functional sourcing partners, domestic contractors, and global resources; ability and interest to work across cultures and geographies

Preferred Skills

• 3+ years’ experience managing a team of clinical schedule managers; completing people management responsibilities including both performance and talent management activities
• Demonstrated ability to handle change management; influence and drive strategies for implementation in operational area and collaborate with other leaders
• Demonstrated success in championing and driving proficiency and compliance with standard processes
• Strategic thinking - ability to turn strategy into tactical activities and operational objectives; Demonstrated experience leading strategic and departmental initiatives
• Familiarity and ability to comprehend statistical analysis methods and clinical data management concepts
• Ability to anticipate stakeholder and regulatory requirements
• Demonstrated ability to work across cultures and geographies
• Active in professional societies
• Experience in process improvement

Required Skills

Functional Strategy, Item Response Theory (IRT), Organizational Leadership, People Management, Program Delivery Management, Program Management, Stakeholder Relationship Management, Statistical Analysis, Strategic Objectives, Strategic Planning, Strategic Thinking, Strategy Deployment, Strategy Development

Preferred Skills

Agile Thinking, Change Management, Process Improvements

US And Puerto Rico Residents Only

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The salary range for this role is

$190,800.00 - $300,300.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

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. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status

Regular

Relocation

Domestic

VISA Sponsorship

Yes

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

10/9/2026

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R417967