Senior Statistician I/II

Reposted Yesterday
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3 Locations
Remote
Senior level
Biotech • Pharmaceutical
The Role
Senior statistical programmer responsible for designing and analyzing clinical studies, producing and QCing CDISC-compliant datasets and TLFs, providing peer review, ensuring regulatory compliance, managing project work and mentoring team members, and liaising with sponsors and lead statisticians.
Summary Generated by Built In

If you are an experienced statistical programmer who is comfortable moving between statistical leadership and hands on programming, this role offers the scope and responsibility to match your expertise.

We are looking for a Senior Statistical Programmer II to act as a senior technical resource across both statistics and programming functions, with primary alignment to the statistics group. You will play a central role in delivering high quality clinical trial outputs while supporting, reviewing and strengthening the work of others.

What you will be responsible for

You will contribute at a senior level across the full clinical trial reporting lifecycle. This includes:

  • Designing and analysing clinical studies, including input into protocols, Statistical Analysis Plans and sample size calculations
  • Programming and quality controlling derived datasets and CDISC compliant datasets
  • Producing and reviewing Tables, Listings and Figures
  • Providing peer review of statistical and programming deliverables
  • Ensuring all outputs meet internal SOPs, client requirements and regulatory expectations

You will manage assigned project work independently, communicate clearly with sponsors when required, and flag risks that could affect timelines or data quality. High standards and attention to detail are essential.

Technical expertise required

You will bring:

  • Strong grounding in statistical principles and modelling
  • Advanced proficiency in SAS and R for dataset and TLF production
  • Excellent knowledge of CDISC standards
  • A solid understanding of ICH/GCP guidelines and the regulatory environment
  • Experience across multiple study phases and therapeutic areas

This role requires someone who understands not just how to produce outputs, but why they are structured the way they are, and how they will be scrutinised in a regulatory setting.

Leadership and collaboration

You will line manage assigned team members, providing mentorship, training and performance feedback. Responsibilities include:

  • Ongoing supervision and support
  • Timesheet approval and resource oversight
  • Contribution to annual and interim performance reviews
  • Monitoring billability and functional KPIs

You will work closely with Lead Statisticians and Lead Programmers to coordinate delivery and may deputise for a Senior Statistical Programmer III when required. Externally, you will interact directly with clients and contribute to study calls and project meetings.


Requirements
  • MSc in Statistics or a mathematics based degree with substantial statistical content
  • Strong experience as a statistician in a CRO
  • Broad experience across clinical trial phases and therapeutic areas
  • Strong analytical and problem solving capability
  • Clear written and verbal communication skills, including the ability to explain statistical concepts to non statisticians

Benefits
  • Competitive Salary (Open to discussion based on experience)
  • Home working allowance
  • Flexible working hours
  • 25 days Annual leave plus bank holidays
  • Option to purchase additional days holiday
  • Pension with Company matching
  • Private medical Scheme with Bupa
  • Free standard eye test every two years
  • Employee Assistance Program – Available for employee and immediate family
  • 5, 10, 15 years of service recognition awards
  • Death in service scheme
  • Long Term Disability Insurance
  • Quanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e-learning, job shadowing)

Skills Required

  • MSc in Statistics or mathematics-based degree with substantial statistical content
  • Strong grounding in statistical principles and modelling
  • Advanced proficiency in SAS and R for dataset and TLF production
  • Excellent knowledge of CDISC standards and producing CDISC-compliant datasets
  • Solid understanding of ICH/GCP guidelines and the regulatory environment
  • Strong experience as a statistician in a CRO and across multiple clinical trial phases
  • Experience producing and reviewing Tables, Listings, and Figures (TLFs) and derived datasets
  • Experience supervising, mentoring or line managing team members
  • Clear written and verbal communication skills, including explaining statistical concepts to non-statisticians
  • Strong analytical and problem solving capability
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The Company
HQ: Hitchin
222 Employees
Year Founded: 1994

What We Do

Quanticate is a leading global data focused clinical research organisation (CRO) primarily focused on the management, analysis and reporting of data from clinical trials and post-marketing surveillance. As experts in clinical data, Quanticate provides high quality teams that offer efficient outsourcing solutions for: • Clinical Data Management • Biostatistics • SAS Programming • Data quality oversight via Centralized Statistical Monitoring • Medical writing • Pharmacovigilance Quanticate can offer study level support, functional service provision (FSP), strategic full data-services solutions or technical consultancy to meet the needs of pharmaceutical, biotechnology and device companies across the globe. Quanticate has become the supplier of choice for many companies from top tier pharmaceutical giants through to niche biotechnology and device companies.

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