[Hiring] Principal Statistician @Chiesi Group

Role Description

This is what you will do:

• Provide statistical expertise and contributions for projects and protocols in support of Drug Development Programs.
• Provide statistical expertise on regulatory submissions and ensure quality and appropriateness of submission deliverables.
• Oversee statistical support to planning, preparation, review, and interpretation of data for clinical trials (interventional, observational, and registries studies).

You will be responsible for:

• Providing statistical input in support of Drug Development Programs.
• Working with other functions in assessing and leveraging data for meaningful, fit-for-purpose summarization.
• Providing statistical support and leadership for study design, sample size calculation, patient randomization, statistical methods and analyses, analysis, and interpretation of data, reporting of results.
• Performing or supervising statistical activities for clinical trials; interacting with CROs and other external vendors when activities are outsourced.
• Reviewing abstracts, posters, presentations, and manuscripts for publications.
• Reviewing Clinical Study Reports.
• Collaborating in writing regulatory documents and managing the statistical deliverables required by eCTD submission.
• Addressing any queries on statistical topics from regulatory agencies.
• Participating in regulatory audits/inspections as required and attending meetings with regulatory agencies to support drug registration.
• Reviewing/developing the Statistical Analysis Plan, including review or development of the definition of derived data sets, statistical tables, figures, and data listings for clinical summary reports.
• Planning, reviewing, and conducting high-quality statistical analyses, post-hoc analyses, exploratory analyses, or analyses requested by regulatory agencies, interacting with SAS programmers as needed.
• Leading all statistical activities for the Data Review Meeting or interacting with CRO statisticians when activities are outsourced.
• Supervising and supporting the operational activities of statistical programmers.
• Sharing relevant knowledge and experiences with colleagues in internal meetings and providing instructions to more junior statisticians.
• Participating and presenting, where appropriate, in educational activities.
• Demonstrating leadership in creating and promoting an environment of teamwork, clearly communicating the expectations and objectives of the data analysis component of a project.
• Working as a member of a team to achieve all outcomes.
• Contributing to the definition of Standard Operating Documents, if needed.
• Performing all work in accordance with established regulatory requirements ensuring compliance with GCP, GCDMP, and CFR 21.11 guidelines, maintaining an in-depth knowledge of these documents.
• Participating in the Chiesi recruitment program as needed.
• Ensuring compliance with Safety and Employment policies (e.g., Respect in the Workplace - Prevention of Violence and/or Harassment).

Qualifications

• PhD or MSc degree in Statistics.
• A significant (>10 years) experience in statistics applied to clinical trials acquired within pharmaceutical companies or CROs.
• Strong knowledge of drug development process and regulatory requirements (such as ICH/GCP).
• Strong statistical methodology knowledge with application to drug development and clinical trials.
• Capability to provide statistical leadership to cross-functional teams at a project/study level.
• Strong communication skills with the ability to communicate complex statistical concepts to a non-statistical audience.
• The ability to investigate data and suggest appropriate analysis to aid cross-functional decision making.
• Good knowledge of international standards for data collection (CDISC).
• Proficiency in using SAS System to conduct analysis.
• Knowledge of tools for sample size calculation.
• English fluent.

Requirements

• Experience in clinical trials for rare diseases, including study design and statistical analysis approaches typically used in small population trials.
• Experience applying adaptive design and/or Bayesian approaches to study design and analysis.
• Experience in interactions with Regulatory Agencies, researchers, and healthcare professionals.
• Experience with studies across all phases of clinical development.
• Knowledge of R or other statistical programming languages.

Benefits

• Comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme, and more.
• Annual bonus scheme, subject to company and individual performance.
• Access to resources and training in a dynamic, friendly environment.
• Competitive salary package, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market.
• Flexible working arrangements and remote work options.
• Tax assistance services for foreign colleagues.