Statistical Programming Manager

3 weeks ago

Bengaluru, Karnataka, India Elanco Full time
About Elanco

At Elanco, we're dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. Our vision is to 'Food and Companionship Enriching Life,' and we're committed to advancing the health of animals, people, the planet, and our enterprise through our approach to sustainability – the Elanco Healthy Purpose.

Job Summary

We're seeking a highly skilled Statistical Programming Manager to join our team. As a key member of our global organization, you'll provide comprehensive programming leadership and support to clinical project teams, ensuring the delivery of high-quality and timely results.

Key Responsibilities
  • Provide strategic programming leadership and support to clinical project teams, including the deployment of programming strategies, standards, and specifications.
  • Develop, validate, troubleshoot, and maintain complex programs and utilities in accordance with regulatory requirements and company standards.
  • Lead the electronic submission preparation and review process, ensuring compliance with regulatory requirements and company standards.
  • Participate in internal and external audits and regulatory inspections as required.
  • Manage all study and non-study related statistical deliverables and resources allocation in a project.
  • Keep project team members informed of programming progress and issues requiring their attention.
  • Manage scheduling and time constraints across multiple projects, set goals based on priorities from management, and adapt to timeline or priority changes.
  • Negotiate and establish accurate time estimates for completion of study programming activities with internal team members and statistical programming management.
  • Prepare for internal meetings, contribute ideas, and demonstrate respect for opinions of others.
  • Display willingness to work with others and assist with projects and initiatives as necessary to meet the business needs.
  • Effectively utilize current technologies and available tools for conducting analyses.
  • Ensure scientific integrity and animal welfare in all activities.
  • Interact with global statisticians and other stakeholders.
  • Create and maintain standard macros and applications to improve the efficiency of the department.
  • Identify opportunities and proactively participate in and/or lead process/quality improvement initiatives, standardization, and other non-clinical initiatives.
  • Develop wider knowledge of SAS and other relevant programming languages and processes within the GO, Biostatistics, and Medical arenas.
  • Contribute to the mentoring of other programmers, developing training courses, presenting training materials, providing feedback, or guiding new associates in process.
  • Engage in knowledge share activities.
  • Ensure scientific integrity and animal welfare in all activities.
  • Train, mentor, and coach global team members on programming concepts.
Requirements
  • Master's degree in computer science, statistics, biostatistics, mathematics, or a related field.
  • 7-9 years of relevant experience.
  • 0-3 years of experience managing highly competent and analytics-oriented teams through project or people management.
  • In-depth knowledge of SAS programming and latest relevant technologies.
  • Strong GxP knowledge, in particular GLP, GCP, and GMP.
  • Good written and verbal communication skills.
  • Demonstrated leadership capability and proven ability to lead teams towards a common goal.
  • Demonstrated planning and organizational skill.
  • Experience in problem-solving and conflict resolution skills.
Preferred Qualifications
  • Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others.
  • Capable of independently and effectively organizing and managing multiple assignments with challenging timelines.
  • Ability to solve complex problems.
  • Sound understanding of operational Regulatory and R&D principles.
  • Ability to communicate logically and technically.
  • Ability to work additional hours as required and work with staff in irregular time zones.
Language

English

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