Senior Biostatistician FSP

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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, motivate your teams to do great work, collaborate easily with clients, and consistently push clinical development forward.

Our Senior Biostatisticians perform ad-hoc or exploratory analyses to support submissions or Health Authority Questions. Exposure to regulatory work is a bonus, as is experience translating regulatory questions into statistical problems, collaborating effectively with clinical and regulatory colleagues. You will support medium-complexity clinical trials from design to archival experience and some project-level activities.

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• Providing statistical support to clinical studies.
  
• Participating in the development of study protocols, including design discussions and sample size calculations.
  
• Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis datasets and TLG specifications.
  
• Performing statistical analyses and interpreting results.
  
• Preparing clinical study reports, including integrated summaries for submissions.
  
• Utilizing strong communication skills to present and explain methodology and decision consequences.
  
• Understanding and following FDA regulations that affect the reporting of clinical trial data, including GCP and guidelines for electronic submissions.
  
• Contributing to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros.
  
• Participating in the development of CRFs, edit check specifications, and data validation plans.
  
• Providing review and/or author data transfer specifications for external vendor data.
  
• Collaborating with internal and external functions (e.g., CROs, software vendors, clinical development partners) to ensure project timelines and goals are met.
  
• Providing review and/or author SOPs and/or work instructions related to statistical programming practices.
  

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• Masters 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 strongly desired.
  
• Expertise in sample size calculation, protocol concept development, SAP, and preparation of clinical study reports including integrated summaries.
  
• Good SAS programming skills for QCing critical outputs, efficacy/safety tables, and working closely with programmers; R programming knowledge is a plus.
  
• Solid understanding and implementation of CDISC requirements for regulatory submissions.
  
• Proficiency in ADaM specifications generation and dataset QC.
  
• Strong ability to build external and internal relationships and motivate a regional or global team.
  
• Effective communicator: ability to explain methodology and decision consequences in lay terms.
  

Here at Cytel, we want our employees to succeed and enable this success through consistent training, development, and support.

Cytel Inc. is an Equal Employment / Affinity Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.