Manager, Biostatistics
Company: Horizon Therapeutics
Location: Bethesda
Posted on: March 14, 2023
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Job Description:
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 studiesRepresent Biostatistics in project
team meetings and other project activitiesServe 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 databasePerform SAS programming validation, and statistical
analyses for clinical publications and other communications if
neededProvide statistical expertise and leadership to ensure
program objectives are in alignment with regulatory and commercial
needsCollaborate with clinical development, project management,
regulatory affairs, medical affairs, Patient Safety and
Pharmacovigilance (PSPV), business development, and commercial
functionsImplement innovative statistical techniques that will
provide benefit to Horizon clinical development programsReview and
manage biostatistics and statistical programming tasks outsourced
to vendorsEnsure timeliness and quality of deliverablesSupport the
preparation of regulatory submissions documents including summaries
of clinical safety and efficacy of BLAs/NDAs if neededTravel 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
skillsExcellent written and verbal communication skillsExcellent
interpersonal and project management skillsComprehensive 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 timelinesMust be solution-oriented and
willing to educate study team members in appropriate interpretation
of designs and resultsOur ValuesTransparency: 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 employeesEnterprise Mindset: Look beyond one's
team, brand or function to see the broader company and external
perspectiveExhibit Intellectual Curiosity: Seek to understand what
you do not know; ask the right questions of the right people and
sourcesEnsure Accountability and Courage: Step up to address
difficult issues and hold self and others accountable to
commitmentsEmbrace Diverse Perspectives: Welcome others with a
respectful attitude; integrate diverse perspectives into ways of
workingDevelop 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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