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Senior Biostatistician

ID:  1809
Date of Posting:  Aug 5, 2025
Business Area:  Clinical
Job Type:  Direct Employee
On site / Remote / Hybrid:  Hybrid
Location: 

Milano, IT Hemel Hempstead, GB

Territory: 
Full-Time or Part-Time:  Full Time
Seniority:  Mid-senior

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

Recordati is seeking an experienced and driven Senior Biostatistician to join their R&D Operations team, with a hybrid focus on clinical trial design and the generation of real-world evidence (RWE).

This dual-role offers a unique opportunity to work at the intersection of regulated clinical research and real-world data (RWD) analytics, helping to shape decision-making across the drug development continuum—from early-phase trials to post-marketing studies.

The successful candidate will apply rigorous statistical approaches to both interventional and observational studies, contribute to clinical development strategy, and ensure statistical integrity in submissions to health authorities and peer-reviewed journals. This role is ideal for a biostatistician who is enthusiastic about expanding their influence beyond traditional trial work and into data-driven, real-world decision-making that impacts patient care and market access globally

Key Responsibilities

Overall:

  • Provide methodological support for data management and analysis of studies on new/marketed drugs, including data pooling.
  • Enhance and update technical knowledge of new statistical methods.

Main Tasks & Responsibilities:

Clinical Development:

  • Design, analyze, and interpret Phase I–IV clinical trials according to regulatory/scientific standards, collaborating on strategic approaches and operational requirements.
  • Provide statistical input for key documents: clinical development plans, protocols, data management plans, CRFs, clinical study reports, and safety/efficacy summaries.
  • Collaborate with cross-functional teams (Clinical Operations, Medical Affairs, Regulatory Affairs) to ensure accurate and timely statistical deliverables.

Real-World Evidence (RWE):

  • Design and execute observational studies using diverse RWD sources (claims, EHRs, registries, digital health).
  • Apply causal inference techniques (e.g., propensity score methods, inverse probability weighting, marginal structural models).
  • Contribute to evidence generation plans for regulatory filings, HTA submissions, label expansions, and post-authorization safety studies.
  • Participate in real-world effectiveness studies, external control arm development, and burden of disease analyses.
  • Prepare SAS programs for statistical analyses and output (tables, listings, figures), collaborating with programmers.
  • Provide statistical input for scientific publications and public event presentations.
  • Attend Project Teams for technical support.
  • Interact with Drug Safety Unit for pharmacovigilance data evaluation (signal detection).
  • Interact with Medical Department (CPL, CRA) and Clinical Operations (drug supply officer, medical writer) for clinical study data preparation and analysis.
  • Lead development, maintenance, and adherence to divisional SOPs and guidelines.

Required Education

Advanced degree or equivalent education/degree in mathematical sciences.

Required Skills and Experience

  • Minimum of 3-5 years of experience in a pharmaceutical company or a contract research organization as a senior statistician.
  •  Extensive experience in clinical trials.
  • Experience in NDA development and submission.
  • Involvement in cross-functional, multicultural, and international clinical trials.
  • Preferable: Rare disease experience.
  • Preferable: Good understanding of the overall drug development process.

Technical Competencies

  • Comprehensive understanding of theoretical and applied statistics
  • Knowledge and use of SAS system.
  • Knowledge of CDISC standards.

Required Behaviours and Competencies

  • Strong adaptability to evolving project requirements, guidelines, and industry standards.
  • Proven ability to work either independently or in a team.
  • Excellent communication skills, both written and verbal.
  • Proven ability to interact effectively within a cross-functional team and with external experts.
  • Proven ability to report project details clearly to various stakeholders within and outside of the company.
  • Demonstrated ability to anticipate and resolve problems on projects.
  • Commitment to continuous professional development, to stay updated on the latest developments in scientific research.

Required Languages

Fluent English (oral and written)

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.

Apply now »