Manager Statistical Programming
3 months ago
At Elanco (NYSE: ELAN) – it all starts with animals
As a global leader in animal health, 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.
At Elanco, 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.
Making animals’ lives better makes life better – join our team today
Functions, Duties, Tasks:
Technical:
Provide comprehensive programming leadership and support to clinical project teams, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices.Independently develop, validate, troubleshoot, and maintain complex programs and utilities in accordance with requirementsEnsure all deliverables are delivered with high-quality and according to timelines.Lead the electronic submission preparation and reviewParticipate in internal/external audits and regulatory inspections as required.Follow applicable SOPs and relevant regulatory guidelines.Manage all study or non-study related statistical deliverables and resources allocation in a project(s).Keep project team members informed of programming progress and issues requiring their attention.Manage scheduling and time constraints across multiple projects at a time, set goals based on priorities from management, and adapt to timeline or priority changes by reorganizing daily workload.Negotiate and establish accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and complete project programming activities within timeframe allotted.Prepare in advance 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 needs of the business.Effectively utilize current technologies and available tools for conducting the 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.People Leadership:
Effectively recruit, lead, manage, develop, evaluate, reward, motivate and retain a group of programmers, on a day-to-day basis. Provide guidance to employee's development plans and carry out performance review and feedback. Develop performance metrics for staff.Meet regularly with direct reports, focusing on project updates, development needs, issue resolution, and provide real-time coaching and feedback; hold staff accountable for quality and timeliness of programming activities; ensure staff is compliant with training requirementsCommunicate with management regarding promotions, performance concerns, and retention risksProvide programming expertise to the teamInfluence stakeholders by providing subject matter expertise on programming related itemsIdentify opportunities to improve methodology and provide practical solutions for problems within areaEnsure programming projects are delivered with high-quality and according to timelines.Contribute to cross-functional administrative or process improvement initiative(s)Contribute to department level initiatives.Minimum Qualification (education, experience and/or training, required certifications):
Master’s degree in computer science, statistics, biostatistics, mathematics or related field.7-9 years of relevant experience0-3 years of experience managing highly competent and analytics-oriented teams through project or people managementIn-depth knowledge of SAS programming and latest relevant technologiesStrong 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 goalDemonstrated planning and organisational skillExperience in problem solving and conflict resolution skillsAdditional Preferences:
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 timelinesAbility 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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