Principal Biostatistician

Join us in playing an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes!

Cytel provides unrivalled biostatistics and operations research to improve drug development success rates, crucial for human welfare. Focused on using innovative applications of statistical science and adaptive clinical trial design, Cytel is at the cutting edge of technology and human ingenuity, driving healthcare forward.

We are hiring a remote Senior/Principal Biostatistician to lead and support clinical trials for a biotech company in the therapeutic area of neuroscience.  This position reports to the Director, Biostatistics in the FSP Services business unit in Cytel.  The level of the position will be determined by the candidate’s experience level.

Your Impact

As a Senior/Principal Biostatistician, you will provide statistical input to support Phase 1 studies in depression, schizophrenia, and other psychiatry diseases, as well as, in Ph 3 studies in depression.

What we are looking for:

• Master’s or PhD in Bioinformatics, Biostatistics or related field
• 5-7 years’ experience in clinical trials, with experience serving as a clinical study lead
• Very good knowledge of research methodology and statistical approaches to analyzing data
• Experience working in Phase 1a/1b studies in neuroscience or neurology areas including IND, SAD/MAD, DDI, PK bioavailability, food effect, etc. and familiar with their study design, protocol, SAP, eCRF, TLF, CSR development
• Comfortable serving in lead Biostatistician role interacting with cross-functional team and joining team meetings, interact with CRO
• Experience with MMRM, multiple imputations, questionnaire-based scales, PROs.
• Good working knowledge of the pharmaceutical industry and regulatory requirements for the drug development
• Good knowledge of SAS programming, will have SAS programmers to work with
• The knowledge of adaptive design and simulations is a plus, but not mandatory 
• Effective communicator:
  • able to explain methodology and consequences of decisions in lay terms
  • able to summarize questions from statistics team over to programmers
• Team player; willingness to go the extra distance to get results, meet deadlines, etc.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment
• Ability to manage multiple projects in a fast-paced environment
• Ability to be flexible when priorities change and deal with ambiguity
• Excellent organizational and time management skills
• Detailed-oriented

Relevant statistical techniques needed:

• Experience with applicable statistical techniques (Mixed models for repeated measures, regression models, parametric and non-parametric methods, multivariate modeling)
• Experience with randomized controlled trials and observational studies
• Experience with relevant ICH guidelines
• Experience with CDISC standards

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