Principal Biostatistician FSP - Hybrid Model

Cytel - EMEA; Greater London; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading biopharmaceutical company in the UK seeks a Principal Biostatistician to provide statistical support for Phase I-III clinical studies focusing on Rare Diseases. Responsibilities include developing protocols, performing analyses, and preparing reports. Candidates should have a Master's degree in Statistics and 8+ years' experience in the Pharmaceutical or Biotechnology sector. Proficiency in SAS, strong communication skills, and a team-oriented mindset are essential for this critical position.

Qualifications

• 8+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
• Experience in sample size calculation and protocol development.
• Strong knowledge of ICH guidelines.

Responsibilities

• Provide statistical support to clinical studies focusing on Rare Disease.
• Develop study protocols and perform statistical analyses.
• Prepare clinical study reports including integrated summaries.

Skills

Statistical analysis

SAS programming

Statistical methodology communication

Team collaboration

Project management

Education

Master's degree in statistics or related discipline

PhD in statistics (strongly desired)

Tools

SAS

R programming

Job description

JOB DESCRIPTION

As Principal Biostatistician, adept at utilizing advanced statistical methods, you will support or lead one or more Phase I-III clinical studies, with a focus on multiple therapeutic area with a focus on Rare Disease.

RESPONSIBILITIES

• Providing statistical support to clinical studies, with a focus on Rare Disease;
• Participating in the development of study protocols, including participation in study design discussions and sample size calculations;
• Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications;
• Performing statistical analyses;
• Interpreting statistical results;
• Preparing clinical study reports, including integrated summaries for submissions;
• Leading study activities when called upon;
• Utilizing your strong communication skills to present and explain methodology and consequences of decisions in lay terms;
• Serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.

QUALIFICATIONS

What we’re looking for:

• Master’s degree in statistics or a related discipline. PhD strongly desired.
• 8+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired.
• Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions.
• Knowledge and implementation of advanced statistical methods, like longitudinal data analyses, missing data imputations, Survival analyses, etc.
• Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables and working closely with Programmers. Knowledge of R programming a plus.
• Strong knowledge of ICH guidelines.
• Solid understanding & implementation of CDISC requirement for regulatory submissions.
• Adept in ADaM specifications generation and QC of datasets.
• Submissions experience is preferred.
• Experience working with cross-functional teams and represent stat group.
• Effective communicator: able to explain methodology and consequences of decisions in lay terms.
• Team player; willingness to go the extra distance to get results, meet deadlines, etc.
• Ability to be flexible when priorities change and deal with ambiguity.