About the job
Alcon is looking to hire Statistical Programming who is responsible for driving productivity and accuracy relative to set strategies and objectives across the AGS regulatory operations team.
Summary Of Position:
Key contributor responsible for quality, timely and cost efficient execution of all statisticalprogramming aspects of assigned studies or project-level activities
Customary point of contact for Trial Statisticians and other members of the Clinical TrialTeam
Key Responsibilities:
Lead statistical programming activities as Trial Programmer for assigned studies or project-level activities including requirements analysis, resource estimation,planning and tracking, development of programs and validation of deliverables
Develop and review programming dataset specifications
Coordinate activities of all programmers assigned to the same study or project. Conductkickoff meeting to provide an overview of the study or project, discuss deliverables, rolesand responsibilities, timelines, and conventions
Remove barriers to facilitate quality, timely and efficient completion of deliverables. Ensurethat programmers have all required inputs for their tasks
Provide solutions to programming issues and/or ensure efficient implementation.
Build and maintain effective working relationships with relevant team functionalrepresentation. Effectively communicate the status of deliverables, changes to plan, risksand proposed mitigation strategy to relevant team, Project Programmer and supervisor
Contribute to development of SP standards and processes, knowledge sharing
and other tasks as assigned
Responsible for quality control and audit readiness of all assigned statistical
programming deliverables as well as accuracy and reliability of statistical analysis results
Key Requirements/Minimum Qualifications:
Quality and timeliness of all deliverables for assigned studies or project-level activities
Ability and effectiveness in leading activities and coordinating programmers
assigned to the same study or project
Adequate representation as Trial Programmer in the Clinical Trial Team.
Effectiveness of communication and participation as assessed by the team
members
Compliance with internal and external standards as measured by audit findings
Works effectively under minimal supervision of supervisor or Project Programmer who is responsible for the overall statistical programming strategy for the project
Timely and high quality SP deliverables. Delays and errors in deliverables may impedesubmissions or other product developments and subsequent revenue loss to the company
Efficient programming leading to quality submissions, and reduced time and costs fordevelopment and registration
Ensuring external quality reputation of Alcon with Health Authorities
Strong SAS programming skills including development and use of macros
Extensive experience in requirements analysis, resource estimation, planning and tracking deliverables and coordinating activities
Extensive experience in developing programming dataset specifications
Good working knowledge of statistical concepts
Good understanding of regulatory requirements relevant to Statistical Programming (e.g.GCP, ICH) and industry standards such as CDISC
Excellent written and oral communication
Ability to work well with others globally
BA/BS/MS degree or equivalent experience in mathematics, statistics, computer science, healthsciences or related field
Minimum Requirements
5 years of relevant programming experience
2 years of proven ability to lead statistical programming activities as Trial Programmer
Preferred Requirements
Relevant programming experience is in the pharmaceutical or medical device industry
Work hours: 1PM to 10PM IST
Relocation assistance: Yes
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