Manager - Biostatistics
Company: Horizon Therapeutics
Location: Bethesda
Posted on: March 17, 2023
Job Description:
At Horizon Therapeutics, we define success by the number of
lives touched, lives changed, and lives saved. Our global
biotechnology company is made up of agile, out-of-the-box thinkers
with a focus on delivering breakthrough medicines to those living
with rare, autoimmune, and severe inflammatory diseases. This is
the heart of our global mission. Start a career that enables you to
live up to your potential and help others live up to theirs. Join
us. The exceptional support we provide patients and communities
equally extends to our employees. We offer industry-leading and
award-winning benefits, compensation and rewards programs that
positively impact all areas of our employees' personal and
professional lives. Position Summary: The primary role of this
position is to provide statistical support across all phases of
clinical development and apply statistical principles and
techniques to a wide range of problems within the clinical
development environment with supervision of senior Biostatistics
staff.Responsibilities:
- Function as independent project statistician for multiple
clinical studies
- Represent Biostatistics in project team meetings and other
project activities
- Serve as primary author for statistical sections of protocol
and create accompanying statistical documents (eg. statistical
analysis plan and mock tables, listings, and figures (TLFs)
shells)
- Participate in development of interactive response technology
(IRT) specifications and EDC database
- Perform SAS programming validation, and statistical analyses
for clinical publications and other communications if needed
- Provide statistical expertise and leadership to ensure program
objectives are in alignment with regulatory and commercial
needs
- Collaborate with clinical development, project management,
regulatory affairs, medical affairs, Patient Safety and
Pharmacovigilance (PSPV), business development, and commercial
functions
- Implement innovative statistical techniques that will provide
benefit to Horizon clinical development programs
- Review and manage biostatistics and statistical programming
tasks outsourced to vendors
- Ensure timeliness and quality of deliverables
- Support the preparation of regulatory submissions documents
including summaries of clinical safety and efficacy of BLAs/NDAs if
needed
- Travel as needed to execute assigned responsibilities and
tasksQualifications and Skills Required:
- PhD in statistics or related field and at least 1 year of
industry experience or MS in statistics or related field and at
least 3 years of industry experience.
- Proficient in Microsoft Office.
- Professional, proactive demeanor.
- Strong interpersonal skills
- Excellent written and verbal communication skills
- 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 resultsOur
Values
- Transparency: We value collaboration. Trusting teach other and
tackling tough challenges can make a powerful difference.
- Accountability: We do what's right for our patient communities
through quality decisions and owning our successes and
failures.
- Growth: We fiercely innovate and evolve to better ourselves,
our communities and our patients.These three values come to life
through our five Leadership Expectations that apply to all Horizon
employees
- Enterprise Mindset: Look beyond one's team, brand or function
to see the broader company and external perspective
- Exhibit Intellectual Curiosity: Seek to understand what you do
not know; ask the right questions of the right people and
sources
- Ensure Accountability and Courage: Step up to address difficult
issues and hold self and others accountable to commitments
- Embrace Diverse Perspectives: Welcome others with a respectful
attitude; integrate diverse perspectives into ways of working
- Develop Talent: Provide feedback, coaching and mentorship to
help others be more effective in their roleAt Horizon, we know that
disease does not discriminate. We embrace the bold ideas of one
another, foster a sense of belonging, and value inclusion. We
attract and develop diverse talent because we believe that when
people from different backgrounds and life experiences come
together, we make lives better. Horizon intends that all qualified
applications are given equal opportunity, and that selection
decisions be based on job-related factors. We do not discriminate
based on race, color, religion, gender, sexual orientation,
national origin, age, disability, veteran status, or any other
characteristics protected by law.
Keywords: Horizon Therapeutics, Bethesda , Manager - Biostatistics, Executive , Bethesda, Maryland
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