Biostatistician Specialist Milano

Biostatistician Specialist
Milano
Lombardia, Milano

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4, 300 employees.

We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, 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. _

**Your contribution/mission

As Biostatistician specialist you 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.

You will improve and update the technical know-how about the new statistical methods.

Your tasks and responsibilities:

- Statistical and data management input provided by the group to all major documents, including clinical development plans, protocols, data management plans, case report forms, clinical study reports, summaries of clinical safety and efficacy.

- Analysis the data and evaluation the results from clinical studies or meta-analyses.

- Development of the statistical analysis plan and programming tables in electronic format.

- Performing review for clinical study protocols and statistical/data management documents generated by others.

- Programming in SAS to perform statistical analyses and prepare the output tables and listings.

- Interaction with R&D Quality Assurance Unit in auditing the Contract Research Organizations and study sites.

- Interaction with the Drug Safety Unit to evaluate the data from the pharmacovigilance database (signal detection).

- Interaction with the Medical department functions (CPL, CRA) to prepare and analyze the data from the clinical studies.

- Interaction with the R&D Quality Assurance Unit to guarantee the quality of the analyses conducted on the study data.

- Close collaboration with Therapeutic Area management in defining strategic approaches to clinical trials and in meeting operational requirements of development plans.

- Attending the Project Teams in order to guarantee the technical support related to the therapeutic area of competence for all the activities foreseen.

- Statistical and data management input in the preparations of scientific publications and study data presentations in public events.

- Leading efforts in the development, maintenance and adherence to divisional SOPs and guidelines.

You will be in charge of the preparation the documents of interest in agreement with estimated timelines and quality standards and the preparation of analyses in agreement with estimated timelines and quality standards

Review of the document/analyses performed by CRO with estimated timelines.

**Your profile

You have a Statistical degree (Statistics, Mathematics) and 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

You are collaborative, good communicator and able to interact with all levels of the organization.

You preferably have knowledge of GCP and CDISC standards.

You know SAS.

**Additional information

Location: Milan, Italy

Direct Manager: Head of Biostatistics & Data Management

LI-HYBRID

- 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. _