Lead Statistician

Date: Aug 16, 2024

Department: Global Clinical Development

Job Type: Direct Employee

Team: R&D, Pharmacovigilance & Regulatory Affairs

Contract Type: Permanent

Location:

Cary, NC, US

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care).
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels.
We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Chiesi USA

Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp™ and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work.
At Chiesi, 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.

What we offer

Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues. Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that “Every one of us is different. Every one of us is Chiesi."

Purpose

To provide statistical leadership to clinical drug development and external opportunity evaluation to ensure appropriate statistical methodology is applied to the assigned project(s)
To represent statistics within the Clinical Development Plan (CDP) team, to support other statistician(s) involved in the project, ensuring consistent approach across studies
To ensure statistical activities of the assigned projects are planned/executed according to regulatory requirements, internal standards, project timelines, under budget control
To maximize the value of project data by data-mining, exploratory analysis to support drug development, hypothesis generation and publications

Main Responsibilities

To 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
To share project related information to statistician(s) involved in the project and oversee their activities to ensure consistent approach across studies
To provide statistical input to submission plan, to represent statistics in interacting with regulatory agencies and Health Technology Assessment (HTA) bodies
To write/review regulatory documents (Briefing Books, eCTD modules)
To lead the preparation of all the statistical deliverables required by regulatory submission (ISS, ISE, data package) ensuring compliance with regulatory requirements
To provide statistical input to product evaluation and due diligence
To maximize the value of data by data mining, post-hoc analysis; to write/review abstracts, posters, presentations for publication
To write/review abstracts, posters, presentations for publication
To contribute to development of internal standards and to process definition / improvement, SOPs writing / review
To contribute to internal initiatives, lessons learned and trainings
To represent statistics for auditing / regulatory inspection
To create and maintain collaborative relationship with external Statistical experts and groups

Experience Required

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.