Current jobs related to Lead Statistician - Cary, North Carolina - Chiesi USA

Chiesi USA is a specialty pharmaceutical company dedicated to developing and promoting innovative products for the hospital, adjacent specialty, and rare disease markets. As a B Corp and Benefit company, we prioritize high social and environmental standards, ensuring the wellbeing of our people, patients, and communities.

We strive to improve people's quality of life by acting responsibly towards society and the environment. Our research, development, and marketing of innovative drugs focus on three therapeutic areas: AIR, RARE, and CAR&E.

At Chiesi USA, we provide a work environment where professionals can build a purposeful career focused on helping others while achieving a fulfilling work-life balance. Our shared values of passion, innovation, trust, and integrity bring out the individual talents and diverse perspectives of each of our colleagues.

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

• 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 assigned projects/studies, including review and approval of key statistical vendor deliverables.
• To share project-related information with statisticians involved in the project and oversee their activities to ensure a consistent approach across studies.
• To provide statistical input to submission plans, represent statistics in interactions with regulatory agencies and Health Technology Assessment (HTA) bodies.
• To write and review regulatory documents, including Briefing Books and eCTD modules.
• To lead the preparation of all statistical deliverables required by regulatory submissions, 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, and writing/reviewing abstracts, posters, and presentations for publication.
• To contribute to the development of internal standards and 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 relationships with external statistical experts and groups.

• 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, including submission preparation and interactions with authorities in different geographical areas.
• Ability to explore and analyze internal and external data, including Real-World data, to investigate clinical questions and maximize product value.
• Experience with product 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.

PhD or MSc degree in Statistics.

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