Principal Biostatistician - Oncology

Our Principal 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.

As Principal Biostatistician, adapt at utilizing advanced statistical methods, you will support or lead one or more Phase I-IV clinical studies. Experience of primarily leading medium complexity clinical trials (starting from Design to Archival experience) and supporting some project-level activities.

Summary of Job Responsibilities:

• Demonstrated experience in project leadership: project planning, interaction with different stakeholders, scientific supervision of statisticians.
• Scientific leader: excellent knowledge and experience in survival analysis, and linear and generalized linear models.
• Capacity to interface effectively with clinicians and statistical programmers.
• Capacity to work independently.
• Capacity to quickly read late development protocols, understand the statistical methodology, and apply it to clinical data.
• Knowledge and practice of CDISC SDTM and ADaM data standards. Ability to work in compliance with the company Analysis and Reporting SOPs and project data standards.
• Able to re-in force the compliance.
• Fast learner, team-oriented, able to work independently.
• Knowledge of SAS programming SAS/STAT SAS/BASE, SAS macro language. Experience with SAS on PC and UNIX platforms.

Qualifications and Experience:

• MSc or Ph.D. in Statistics.
• 8-10 years of relevant clinical trial biostatistics support in design, analysis, and interpretation. Proven experience of work with clinical trialdata in support of safety and efficacy analysis
• Ability to read, write and speak fluently in English.
• CDISC knowledge is required.

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:

• Masters degree in statistics or a related discipline. Ph.D. strongly desired.
• 9+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
• Ability to work independently, demonstrate initiative and flexibility through effective and innovative leadership.
• Attention to detail and quality focused, excellent interpersonal and communication skills, innovative, and collaborative behaviours
• SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers.
• Knowledge of R programming (R Shiny/Python)

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