Director, Statistical Programmer

Horizon Pharma   •  

Lake Forest, IL

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 109 days ago

This job is no longer available.

Working at Horizon Pharma is more than a job – it’s personal. We define success by a different set of numbers: the number of lives touched, the number of lives changed, the number of lives saved. We’re a team of agile, out-of-the-box thinkers who are inspired to do more because we know we’re a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help patients live up to theirs.

Position Summary:

This role leads statistical programming, building the function by developing a vision for statistical programming at Horizon and implementing that vision. The successful candidate will build the organization through leading the acquisition, development and retention of talent, setting up processes and ensuring compliance with regulatory, corporate and departmental requirements and policies. This position is responsible for managing statistical programming IT projects and statistical programmers that populate teams across the entire R&D portfolio - spanning all therapeutic areas and phases of development.

Responsibilities:

  • Identify necessary processes and procedures for statistical programming, implement and reinforce company-wide
  • Drive functional excellence within the statistical programming discipline by establishing and communicating standards for performance and effective talent management
  • Define requirements for technology and platforms needed to implement and enhance statistical programming
  • Hold internal staff and external vendors accountable for quality and timeliness of programming activities supporting teams in clinical development, medical affairs, pharmacovigilance and other organizations across multiple development projects, and ensure all teams are adequately supported
  • Support statisticians and liaise with data managers to ensure seamless transfer of data within the department
  • Effectively recruit, manage, develop, evaluate, reward, and retain direct reports, and ensure direct reports are compliant with all training requirements, relevant regulatory requirements and corporate and departmental procedures and standards
  • Differentially recognize, develop and reward talent that is critical to Horizon and future growth through leadership opportunities and areas of visibility within and external to the company
  • Serve on biometrics leadership team which oversees statistics, data management and statistical programming functions
  • Lead or support continuous improvement initiatives within Horizon and serves as a representative to cross-functional R&D initiatives
  • Enable a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner

Requirements:

  • Undergraduate degree in statistics, biostatistics, mathematics, computer science or equivalent experience; graduate degree preferred
  • Minimum of 10 years clinical/statistical programming experience within pharmaceutical clinical development
  • Minimum 5 years experience in managing technical professionals in a regulated environment; experience starting a new department preferred
  • Significant expertise in programming and developing computing strategies for statistical analysis and reporting
  • Significant knowledge of the drug development process, clinical trial methodology, statistics and relevant regulatory requirements for drug approval, including experience is submitting new drug applications to the FDA
  • Demonstrated ability to operate and lead in a matrix organization, building successful working relationships and effective stakeholder management in an environment with multiple lines of authority and competing needs
  • Demonstrated extensive understanding of SAS programming concepts and techniques, including CDISC standards, regulatory requirements and ICH guidance
  • Medidata experience preferred
  • Ability to be flexible and adapt quickly to the changing needs of the organization
  • Ability to organize multiple work assignments and establish priorities
  • Excellent verbal and written communications skills

Qualifications and Skills Required:

  • Proficient in SAS
  • Proficient in Microsoft Office
  • Professional demeanor
  • Self-starter attitude
  • Strong interpersonal skills
  • Excellent written and verbal communication skills

Horizon Pharma plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.

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