Senior Statistical Leader

1 week ago

Cary, North Carolina, United States Chiesi USA Full time

About Chiesi USA

We are a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. Our mission is to improve people's quality of life by acting responsibly towards society and the environment.

Our Values

We share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work.

Job Summary

We are seeking a Senior Statistical Leader to provide statistical leadership to clinical drug development and external opportunity evaluation. The successful candidate will ensure appropriate statistical methodology is applied to the assigned project(s) and represent statistics within the Clinical Development Plan (CDP) team.

Main Responsibilities

  • Provide scientifically rigorous statistical expertise to clinical development plans, study design statistical analysis, interpretation and communication of statistical results
  • Responsible for quality and timelines of all statistical deliverables of the assigned projects / studies including review / approve key statistical vendor deliverables
  • Share project related information to statistician(s) involved in the project and oversee their activities to ensure consistent approach across studies
  • Provide statistical input to submission plan, to represent statistics in interacting with regulatory agencies and Health Technology Assessment (HTA) bodies
  • Write/review regulatory documents (Briefing Books, eCTD modules)
  • Lead the preparation of all the statistical deliverables required by regulatory submission (ISS, ISE, data package) ensuring compliance with regulatory requirements
  • Provide statistical input to product evaluation and due diligence
  • Maximize the value of data by data mining, post-hoc analysis; to write/review abstracts, posters, presentations for publication
  • Contribute to development of internal standards and to process definition / improvement, SOPs writing / review
  • Contribute to internal initiatives, lessons learned and trainings
  • Represent statistics for auditing / regulatory inspection
  • Create and maintain collaborative relationship with external Statistical experts and groups

Requirements

  • A significant experience in statistics applied to clinical trials acquired within pharmaceutical companies or CROs
  • Advanced understanding of drug development process and regulatory requirements
  • Strong statistical methodology knowledge with application to drug development
  • Strong experience in regulatory activity (submission preparation and interactions with authority in different geographical areas)
  • Ability to explore and analyse internal and external data, including Real World data, to investigate clinical questions and maximize the product value
  • Experience with products evaluation and due diligence
  • Highly effective written, oral and interpersonal communication skills
  • Leadership and ability to work in a matrix organization
  • Problem solving skills and willingness to take ownership of decision-making
  • Ability to prioritize activities, drive for results and strong commitment to quality
  • Ability to drive innovation

Education

PhD or MSc degree in Statistics

Technical Skills

  • Proficiency in SAS System, R, other statistical software
  • Knowledge of tools for sample size calculation

Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one's employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.

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