Associate Director, Biostatistics

Horizon Pharma Lake Forest , IL 60045

Posted 2 months ago

Working at Horizon is more than a job - it's personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. 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 others live up to theirs.

Position Summary:

The primary role of this position is to support planned and ongoing clinical trials including sample size estimation, writing or reviewing statistical analysis plans, reviewing protocols, reviewing tables, listings and figures, and providing input into clinical study reports.

Responsibilities:

  • Lead, develop, and coordinate biostatistical activities for Clinical Development, Clinical Operations, Medical Affairs, and Business Development

  • Provide statistical expertise and leadership to ensure program objectives are in alignment with regulatory and commercial needs

  • Collaborate with project management, regulatory, medical affairs, PV/safety, business development, and commercial functions

  • Evaluate and implement innovative statistical techniques that will provide benefit to Horizon clinical development programs

  • Contribute to strategic planning and go/no go decision guidance

  • Participate in vendor selection for biostatistics, statistical programming, data management, interactive response technology (IxRS), and other services wherein data storage and analysis may be applicable; manage and oversee biostatistics and statistical programming tasks

  • Interact with regulatory agencies and respond to requests

  • Participate in or manage Biometrics participation in risk-based monitoring plans and activities

  • Ensure timeliness and quality of deliverables

  • Travel as needed to execute assigned responsibilities and tasks

Qualifications and Skills Required:

  • PhD in statistics or related field and at least 5 years of industry experience or MS in statistics or related field and at least 8 years of industry experience.

  • Proficient in Microsoft Office

  • Professional, proactive demeanor

  • Strong interpersonal skills

  • Excellent written and verbal communication skills

  • Experience with people management and development of staff

  • Excellent interpersonal and project management skills

  • Comprehensive knowledge of clinical trials methodology (experience with Bayesian methods preferred), regulatory requirements, and statistical software packages. Experience with interventional, observational and retrospective studies. Ability to contribute strategically.

  • Able to collaborate effectively with internal and external study management teams to meet project timelines

  • Must be solution-oriented and willing to educate study team members in appropriate interpretation of designs and results

Horizon Core Values & Competencies:

Growth

  • Manages Ambiguity

  • Strategic Mindset

  • Demonstrates Self-awareness

  • Cultivates Innovation

  • Develops Talent

Accountability

  • Drives Results

  • Ensures Accountability

  • Decision Quality

Transparency

  • Courage

  • Collaboration

  • Instills Trust

Horizon Therapeutics 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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Associate Director, Biostatistics

Horizon Pharma