Principal, Biostatistics Statistical Programming

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon and we are looking for a Principal, Biostatistics Statistical Programming either in Fort Worth, TX or to work remotely.

In this role, a typical day will include:

• Lead onboarding, professional development, training and mentoring assigned programmers Understand SP deliverables, customer expectations and resource requirements. Prioritize tasks, assign resources, and manage plan to optimize resources.

• Forecast short-term and long-term demand for resources

• Generate status reports and metrics

• Lead statistical programming activities as Project 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 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.

Additional Experience:

• Effectiveness in developing, mentoring and managing assigned programmers

• Efficiency of resource utilization and accuracy of resource estimation

• 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

• 5 years of relevant programming experience

• 2 years of proven ability to lead statistical programming activities as Trial Programmer

• Relevant programming experience is in the pharmaceutical or medical device industry

• Proven ability to lead statistical programming activities as Project Programmer

Impact in the Organization:

• 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

Competency Profile:

• Strong leadership, collaboration and organizational skills with proven ability to successfully manage numerous, simultaneous activities and meet deadlines

• 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 interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across functions

• Excellent written and oral communication

• Interviewing, mentoring, coaching, knowledge management