The Senior Biostatistician will provide statistical support for clinical trials, including protocol development, sample size calculations, and the creation of statistical analysis plans. They will also perform statistical analyses, interpret results, and prepare clinical study reports for regulatory submissions.
Who Are You?
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. You motivate others to do the same.
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.
Position Overview:
Our Senior Biostatisticians perform statistical analyses to support clinical trial/marketed product submissions to regulatory agencies. Having exposure to oncology is a bonus.
Responsibilities
As a Senior Biostatistician, your responsibilities will include:
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
Qualifications
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:
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 with oncology is a bonus.
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.
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