Statistical Programming Leadership Position

2 weeks ago

Bengaluru, Karnataka, India Elanco Full time

At Elanco, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.

We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the planet and our enterprise.

As a global leader in animal health, we pride ourselves on fostering a diverse and inclusive work environment.

We believe that diversity is the driving force behind innovation, creativity, and overall business success.

Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Our team is responsible for providing comprehensive programming leadership and support to clinical project teams.

Key responsibilities include:

  • Providing programming strategies, standards, specifications, and programmed analysis to comply with regulatory requirements, SOPs, and work practices.
  • Developing, validating, troubleshooting, and maintaining complex programs and utilities in accordance with requirements.
  • Ensuring all deliverables are delivered with high-quality and according to timelines.
  • Leading the electronic submission preparation and review.
  • Participating in internal/external audits and regulatory inspections as required.
  • Following applicable SOPs and relevant regulatory guidelines.
  • Managing all study or non-study related statistical deliverables and resources allocation in a project(s).
  • Keeping project team members informed of programming progress and issues requiring their attention.
  • Managing scheduling and time constraints across multiple projects at a time, setting goals based on priorities from management, and adapting to timeline or priority changes by reorganizing daily workload.
  • Negotiating and establishing accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completing project programming activities within timeframe allotted.
  • Preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others.
  • Displaying willingness to work with others and assisting with projects and initiatives as necessary to meet the needs of the business.
  • Effectively utilizing current technologies and available tools for conducting the analyses.
  • Ensuring scientific integrity and animal welfare in all activities.
  • Interacting with global statisticians and other stakeholders.
  • Creating and maintaining standard macros and applications to improve the efficiency of the department.
  • Identifying opportunities and proactively participating in and/or leading process/quality improvement initiatives, standardization, and other non-clinical initiatives.
  • Developing wider knowledge of SAS and other relevant programming languages and processes within the GO, Biostatistics, and Medical arenas.
  • Contributing to the mentoring of other programmers, developing training courses, presenting training materials, providing feedback, or guiding new associates in process.
  • Engaging in knowledge share activities.
  • Ensuring scientific integrity and animal welfare in all activities.
  • Training, mentoring, and coaching global team members on programming concepts.

Key qualifications include:

  • Master's degree in computer science, statistics, biostatistics, mathematics, or 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 organisational skill.
  • Experience in problem-solving and conflict resolution skills.

Additional preferences include:

  • 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.

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