Principal Statistician, Global Rare Diseases

This is what you will do

Provide statistical expertise and contributions for projects and protocols in support of Drug Development Programs; to provide statistical expertise on regulatory submissions and ensure quality and appropriateness of submission deliverables; to provide/oversee statistical support to planning, preparation, review and interpretation of data for clinical trials (interventional, observational and registries studies), ensuring that data are analysed and evaluated with appropriate statistical methodologies.

You will be responsible for

• Providing statistical input in support of Drug Development Programs
• Working with the other functions in assessing and leveraging data for meaningful, fit-for purpose summarization

• Provide statistical support and leadership for study design, sample size calculation, patient randomization, statistical methods and analyses, analysis, and interpretation of data, reporting of results

• Perform or supervise statistical activities for clinical trials; when activities are outsourced, interact with CROs and other external vendors
• Review abstracts, posters, presentations, and manuscripts for publications
• Review Clinical Study Reports
• Collaborate in writing regulatory documents. Manage the statistical deliverables required by eCTD submission
• Address any queries on statistical topics from regulatory agencies
• Participate in regulatory audits/inspections as required. Attend meetings with regulatory agencies to support drug registration
• Review/develop 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
• Plan, review and conduct high quality statistical analyses, post-hoc analyses, exploratory analyses, or analyses requested by regulatory agencies interacting with SAS programmers, as needed
• Lead all the statistical activities for the Data Review Meeting or interacts with CRO statistician when activities are outsourced
• Supervise and support the operational activities of statistical programmers
• Share relevant knowledge and experiences with the colleagues in internal meetings and provide instructions to more junior statisticians
• Participate and present, where appropriate, in educational activities
• Demonstrate leadership in creation and promotion of an environment of teamwork, clearly communicating the expectations and objectives of the data analysis component of a project
• Work as a member of a team to achieve all outcomes
• Contribute to definition of Standard Operating Documents, if needed
• Perform 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
• Participate in the Chiesi recruitment program as needed
• Responsible to ensure compliance with Safety and Employment policies (e.g., Respect in the Workplace - Prevention of Violence and/or Harassment)

You will need to have

• 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-funcational 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

We would prefer for you to have

• 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, health care
• Experience with studies across all phases of clinical development
• Knowledge of R or other statistical programming languages

Location

Europe - Remote

Compensation Range

The package outlined below is based on the role being located in Italy. Where the role is offered in a different country, the applicable salary, bonus and benefits will be aligned to the relevant local market and internal frameworks. Full details of the applicable package will be provided at the appropriate stage of the recruitment process.

The minimum salary for this role is € 59.000, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations.

This role is eligible to participate in an annual bonus scheme, subject to company and individual performance.

In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme, and more.