Lead Statistical Programmer

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 statistical programming aspects of assigned studies or project-level activities
Customary point of contact for Trial Statisticians and other members of the Clinical Trial Team

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. Conduct kickoff meeting to provide an overview of the study or project, discuss deliverables, roles and responsibilities, timelines, and conventions
Remove barriers to facilitate quality, timely and efficient completion of deliverables. Ensure that 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 functional representation. Effectively communicate the status of deliverables, changes to plan, risks and 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 impede submissions or other product developments and subsequent revenue loss to the company
Efficient programming leading to quality submissions, and reduced time and costs for development 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, health sciences 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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