Experience
7 - 8 yrs
Job Location
Hyderabad, India
Vacancy
1
Designation
Senior Statistical Programmer
Job Type
Not specified
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
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 (ie 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 (eg 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 (eg 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
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.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
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 (ie 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 (eg 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 (eg 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
No Referrers Available
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