Biostatistics - Sr. Manager - Apply Now
Horizon Therapeutics
Round Lake Beach
biostatistics
manager
horizon
management
regulatory
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clinical development
medical
medical affairs
business development
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November 19, 2022
Horizon Therapeutics
Round Lake Beach
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
Qualifications and Skills Required:
Physical Demands (additions as needed):
Horizon Core Values & Competencies:
Growth
Accountability
Transparency
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.
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
- Support 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
- Implement innovative statistical techniques that will provide benefit to Horizon clinical development programs
- Contribute to strategic planning and go/no go decision guidance
- Review biostatistics and statistical programming tasks outsourced to vendors
- 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 3 years of industry experience or MS in statistics or related field and at least 5 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
Physical Demands (additions as needed):
- Ability to sit and stand for extended periods of time
- Ability to carry, handle and reach for objects
- Manual dexterity to operate office equipment, e.g. computer, phones, etc.
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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