Sr Principal Statistical Programmer

Merck; Hyderabad; On-site; INR 1,800,000 - 2,700,000; Full time

Job summary

Merck is seeking a Project Statistical Programmer to provide leadership, guidance and support to project teams on routine global projects, ensuring quality, timely delivery and regulatory readiness across development programs.

You will take responsibility for statistical programming activities, coordinate with Project Statisticians, Data Management and Clinical Operations, and lead initiatives to improve processes and integration for submissions.

Responsibilities

• 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.
• As a Project Statistical Programmer 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.

Job description

Job Summary

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. As a Project Statistical Programmer 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.

Responsibilities

• 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.
• As a Project Statistical Programmer 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.