Zero - Statistician

Contract Real World Evidence Statistician – RWE Analysis (Zero Hours Contractor)

Location: Remote / Flexible

Contract Type: Zero Hours Specialist Contractor (Time and Materials)

Function: Statistics / Real World Evidence

We are seeking an experienced RWE, Real World Evidence Statistician to provide specialist statistical support for RWE clinical studies on a flexible, zero-hours contract basis. This role focuses on delivering high-quality RWE analyses, quality control activities, and analytical peer review in line with study protocols, Statistical Analysis Plans (SAPs), and regulatory expectations.

This is an ideal opportunity for a contractor who enjoys working independently within a defined analytical scope while collaborating with multidisciplinary clinical development teams.

• Perform standard real world analysis studies
• Provide expert statistical input into the design of observational and non-interventional studies using real world data (RWD)
• Advise on appropriate study designs (e.g. pre/post, cohort, matched comparator, benchmark-aligned analyses) and their limitations
• Define analytically sound frameworks for outcomes reporting aligned to the intended use (e.g. external credibility rather than regulatory submission)

• Act as an independent statistical expert reviewing client-generated RWE analyses
• Provide written and verbal critique of analytical approaches and outputs
• Support refinement of outcomes reporting to improve credibility and external acceptance
• Peer review analyses performed by other statisticians or programmers
• Document QC findings clearly and support issue resolution in line with SOPs and good statistical practice

• Engage directly with sponsors to understand clinical services, data sources, and stakeholder objectives
• Participate in scientific discussions with clinicians, medical leadership, and external partners
• Represent Quanticate as an independent, authoritative biometrics partner in RWE discussions

• Provide internal guidance or training on RWE methodology and good practice
• Contribute to white papers, methodological guidance, or thought leadership content in RWE
• Support development of repeatable RWE analysis frameworks for ongoing client use

• Flexible zero-hours arrangement based on project demand
• Time and materials engagement model
• Opportunity to support a range of early-phase clinical development programmes
• Fully remote working environment

Please submit your CV outlining relevant PK analysis experience and availability for contract work.

• Expert understanding of observational study design and analysis
• Deep knowledge of RWE/RWD principles, strengths, and limitations
• Strong grounding in causal inference concepts, bias, and confounding
• Working knowledge of relevant guidance (e.g. FDA RWE Framework, EMA guidance, ISPOR good practice)
• Minimum qualification:
  
  MSc in Statistics or related quantitative discipline (or equivalent experience)

• Typically 10-15 years' experience in pharmaceutical, healthcare, CRO, or academic settings
• Demonstrated experience delivering independent RWE or outcomes research consultancy
  
  Proven ability to review, challenge, and refine non-interventional analyses
• Experience working with medical record-derived or routinely collected healthcare data

• Proficiency in SAS and/or R; familiarity with real world data structures
• Ability to explain complex methodological issues clearly and proportionately
• Strong analytical accuracy and attention to detail
• Ability to work independently while adhering to defined specifications

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