Senior/Principal Biostatistician FSP

Cytel Inc; Greater London; On-site; GBP 60,000 - 80,000; Full time

Job summary

A global biostatistics firm is seeking a Senior Biostatistician to support phase I-IV clinical studies. The ideal candidate will have a master's degree in statistics (Ph.D. preferred) and over 5 years of experience in the pharmaceutical field. Responsibilities include providing statistical support, developing study protocols, and analyzing data. Strong SAS skills are required, along with the ability to build relationships within teams. This role offers an exciting opportunity to impact patient treatment innovation.

Benefits

Consistent training and development

Collaborative work environment

Qualifications

• 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
• Experience working for a CRO is strongly desired.
• Good SAS programming skills for QCing critical outputs.

Responsibilities

• Providing statistical support to clinical studies.
• Participating in the development of study protocols.
• Reviewing CRFs and developing statistical analysis plans (SAPs).
• Performing statistical analyses and interpreting results.

Skills

Statistical analysis

SAS programming

Communication skills

CDISC compliance

Team collaboration

Education

Master's degree in statistics or related discipline

Ph.D. in statistics or related discipline

Tools

SAS

R programming

Job description

An experienced Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support or lead one or more Phase I-IV clinical studies. You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical development forward to what it could be. Sponsor-dedicated: Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you’ll be at the heart of our client’s innovation. As a Senior Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program., Our Senior Biostatisticians perform ad-hoc or exploratory analyses to support submission or Health Authority Questions. Having exposure to regulatory work experience is a bonus, for example, if you understand the regulatory questions and translating them to statistical problems, collaborating effectively, with clinical and regulatory colleagues. Supporting medium complexity clinical trials (starting from Design to Archival experience) and supporting some project-level activities.

Responsibilities

• Providing statistical support to clinical studies
• 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 and interpreting statistical results
• Preparing clinical study reports, including integrated summaries for submissions
• Utilizing your strong communication skills to present and explain the methodology and consequences of decisions
• Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions
• Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Participate in the development of CRFs, edit check specifications, and data validation plans
• Provide review and/or author data transfer specifications for external vendor data
• Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
• Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:

Qualifications

• Master's degree in statistics or a related discipline. Ph.D. strongly desired.
• 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
• Experience working for a CRO is strongly desired.
• Experience in sample size calculation, protocol concept development, protocol development, SAP, and preparing clinical study reports including integrated summaries for submissions.
• Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers. Knowledge of R programming is a plus.
• Solid understanding & implementation of CDISC requirements for regulatory submissions.
• Adept in ADaM specifications generation and QC of datasets.
• The ability to build strong external & internal relationships and motivate a regional or global team.
• Effective communicator: able to explain methodology and consequences of decisions in lay terms.