Biostatistician

*With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn.

We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.

At Recordati, our mantra is simple. We've always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.

This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.

Recordati. Unlocking the full potential of life.
Job Purpose*
We are looking for a Biostatistician that will provide methodological support and ensure the proper management and analysis of the data from the studies on new drugs or marketed drugs by the Group's companies followed by the CROs or directly including pooling of more studies. The person will improve and update the technical know-how about the new statistical methods.

Key Responsibilities

• You will close collaborate with the Therapeutic Area management in defining strategic approaches to clinical trials and in meeting operational requirements of development plans.
• You will be part of the Project Teams in order to guarantee the technical support related to the therapeutic area of competence for all the activities foreseen.
• You will be in charge of the preparation of the statistical input provided to all major documents, including clinical development plans, protocols, data management plans, case report forms, clinical study reports, summaries of clinical safety and efficacy, as well as in the preparations of scientific publications and study data presentations in public events, and interact with the Medical Writer Unit in their finalization.
• You will develop or supervise the preparation of the statistical analysis plan and the programming of the output (tables, figures and listings) in electronic format.
• You will perform the review of the clinical study protocols and statistical/data management documents generated by others.
• You will analyze the data and evaluate the results from clinical studies or meta-analyses.
• You will program in SAS to perform statistical analyses and prepare the output tables and listings.
• You will Interact with the Medical department functions (CPL, CRA) to prepare and analyze the data from the clinical studies.
• You will Interact with R&D Quality Assurance Unit in auditing the Contract Research Organizations and study sites and to guarantee the quality of the analyses conducted on the study data.
• You will Interact with the Drug Safety Unit to evaluate the data from the pharmacovigilance database (signal detection).
• You will lead efforts in the development, maintenance and adherence to divisional SOPs and guidelines.
• You will review and oversight the document/analyses performed by CRO with estimated timelines.

Required Education
Statistical degree (Statistics, Mathematics)

Required Skills And Experience
3-5 years of experience in a CRO or pharmaceutical company and clinical trials.

You have a clear understanding of theoretical and applied statistic and regulatory guidelines in a pharmaceutical research setting; you are expert in the development and submission of NDA

Technical Competencies
You have knowledge of GCP and preferably CDISC standards.

You know programming in SAS System.

Required Behaviours And Competencies
You are collaborative, good communicator and able to interact with all levels of the organization

Required Languages
Fluent in English

At Recordati we believe in people Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.
We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.
If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.