Senior Biostatistician

Recordati Hemel Hempstead, England, United Kingdom

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.

Key ResponsibilitiesOverall

• 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

• 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.
• 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)

EEO Statements

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 or 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.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Research, Analyst, and Information Technology

Industries

Pharmaceutical Manufacturing

#J-18808-Ljbffr