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.
Clinical Development
Main Tasks & Responsibilities:
- 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)
