Senior Principal Statistical Programmer

Merck Healthcare; Hyderabad; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Merck Healthcare is seeking a Project Statistical Programmer to provide leadership on one or more global projects in Drug Research and Development. You will guide statistical programming activities, ensure quality and timely delivery, and collaborate with project teams and CRO partners to meet regulatory standards.

The role emphasizes e-submission readiness, CDISC compliance, and cross-functional coordination to maximize data quality and project success across therapeutic areas.

Qualifications

• Experience providing statistical programming leadership for global projects.
• Ability to coordinate with CROs and manage outsourced deliverables.
• Knowledge of regulatory guidelines and e-submission readiness.

Responsibilities

• Take overall responsibility and accountability for statistical programming activities within one or more routine Drug Research and Development Program(s)
• Ensure successful quality, planning, execution, monitoring, control and closure of tasks.
• Accountable for working with the Project Statistician, other project team members and key decision makers to proactively plan project level activities and for managing continuous process improvements.
• Ensure that the planning and management of outsourced statistical programming owned deliverables are effectively performed and are conducted to the highest quality and in a timely manner.
• Aid the CRO with prioritization of work when necessary to meet business needs.
• With direction, responsible for ensuring technical readiness for a submission (i.e. that all relevant documents are available and in an e-submission ready format and that all internal and external CDISC and regulatory guidelines requirements are fulfilled), inspections/audits (e.g. ensuring appropriate documentation and traceability according to process and standard tools).
• Ensure relevant standards are applied consistently.
• Ensure maximization of global integratability and interpretability of data. Coordinate with Data Management and Clinical Operation to target high quality databases and specifications at project level.
• Work closely with colleagues in interface roles (e.g. Project Data Manager, Project Statistician), to ensure smooth and efficient running of the project.
• Efficiently perform (and direct teams to perform) complex trial and project level programming tasks, from set up to project close, with all tasks to high quality and efficiency.
• Able to quickly and effectively integrate into different project teams as needed.
• Participate effectively on clinical trial teams and as an ad-hoc member on clinical development teams.
• Accountable for ensuring statistical programming deliverable timelines and quality expectations are met and best practices implemented. Ensures appropriate level of CRO interaction and surveillance.
• With some supervision lead Statistical Programming / Biostatistics initiative teams as required. Develop objectives, milestones, project plan. Monitor progress against the plan and seek guidance and direction as needed.

Skills

Statistical programming

Leadership

Project management

CDISC & regulatory knowledge

Job description

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That’s why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Position Overview

As a project statistical programmer, provide statistical programming leadership, guidance, advice and support to project teams for one or more routine complexity global projects to optimize probability of success of new products. Alternatively function as a Lead Statistical Programmer for multiple clinical trials and / or other global project sub tasks (may be complex), across one or more clinical development programs.

Key Responsibilities

• Take overall responsibility and accountability for statistical programming activities within one or more routine Drug Research and Development Program(s)
• Ensure successful quality, planning, execution, monitoring, control and closure of tasks.
• Accountable for working with the Project Statistician, other project team members and key decision makers to proactively plan project level activities and for managing continuous process improvements.
• Ensure that the planning and management of outsourced statistical programming owned deliverables are effectively performed and are conducted to the highest quality and in a timely manner.
• Aid the CRO with prioritization of work when necessary to meet business needs.
• With direction, responsible for ensuring technical readiness for a submission (i.e. that all relevant documents are available and in an e-submission ready format and that all internal and external CDISC and regulatory guidelines requirements are fulfilled), inspections/audits (e.g. ensuring appropriate documentation and traceability according to process and standard tools).
• Ensure relevant standards are applied consistently.
• Ensure maximization of global integratability and interpretability of data. Coordinate with Data Management and Clinical Operation to target high quality databases and specifications at project level.
• Work closely with colleagues in interface roles (e.g. Project Data Manager, Project Statistician), to ensure smooth and efficient running of the project.
• Efficiently perform (and direct teams to perform) complex trial and project level programming tasks, from set up to project close, with all tasks to high quality and efficiency.
• Able to quickly and effectively integrate into different project teams as needed.
• Participate effectively on clinical trial teams and as an ad-hoc member on clinical development teams.
• Accountable for ensuring statistical programming deliverable timelines and quality expectations are met and best practices implemented. Ensures appropriate level of CRO interaction and surveillance.
• With some supervision lead Statistical Programming / Biostatistics initiative teams as required. Develop objectives, milestones, project plan. Monitor progress against the plan and seek guidance and direction as needed.

Location

Bangalore OR HYD

What we offer

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!