Job Description
JOB DESCRIPTION Who Are You? As a Senior Statistician, you will be dedicated to one of our major Pharma clients, working as an extension of their staff to support or lead clinical trials for drug development, with the opportunity to leverage your experience in all phase's trials and regulatory submissions for Gastrointestinal studies.
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 provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. You will formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use.
RESPONSIBILITIES As a Senior Biostatistician, your responsibilities may 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
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.
- At least 3 years of recent experience on late-phase (II & III) drug development including drafting SAPs/calculating sample size/reviewing TLFs.
- Experience in Gastro-intestinal studies or submission is a plus.
- Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers. Knowledge of R programming is a plus.
- Strong knowledge of full clinical trial process with experience writing SAPs, reviewing and verifying key statistical outputs
- Solid understanding & implementation of CDISC requirements for regulatory submissions.
- Attention to detail and quality focused, excellent interpersonal and communication skills, innovative, and collaborative behaviors
- Team player; willingness to go the extra distance to get results, meet deadlines, etc.
Job Tags
Permanent employment,