Overview
In this role you apply advanced biostatistical methods to support or lead Phase I–IV clinical studies within a sponsor-dedicated setting. You will work closely with cross-functional teams and external partners to translate regulatory questions into robust analyses, advancing clinical development. You’ll design studies, perform analyses, and contribute to regulatory submissions, shaping how data informs patient treatment. This is an embedded, client-facing position with impact across pipelines and teams.
Responsibilities
- Provide statistical support to clinical studies
- Contribute to study design discussions and sample size calculations
- Develop and review SAPs, analysis datasets, and TLG specifications
- Perform statistical analyses and interpret results
- Prepare clinical study reports including integrated summaries for submissions
- Communicate methodology and implications clearly to stakeholders
- Follow FDA regulations and guidelines for electronic submissions
- Contribute to standards for programming tools, outputs, and macros
- Review CRFs, data review guidelines, and data validation plans
- Collaborate with CROs, software vendors, and clinical development partners to meet timelines
- Review and/or author SOPs and work instructions related to statistical programming practices
Key requirements
- 5+ years supporting clinical trials in pharma/biotech
- Experience with SAS programming for QC outputs and efficacy/safety tables
- Knowledge of CDISC requirements for regulatory submissions
- ADaM specifications generation and QC of datasets
- Experience with protocol development, SAP, SAP and TLG specifications
- Experience in sample size calculation and protocol concept development
- Regulatory submission experience is a bonus
- PhD strongly desired
- Experience with CROs is strongly desired
- Strong external and internal relationship-building and communication skills
- collegial collaboration
- effective communication
- mentoring/leading teams
- SAS programming
- R programming (plus)
- CDISC/ADaM
Senior Biostatistician FSP employer: Cytel
Cytel is an exceptional employer that empowers its employees to thrive in a collaborative and innovative environment, particularly for the role of Principal SAS Programmer. With a strong commitment to professional development and training, Cytel ensures that you have the support needed to excel in your career while working remotely with a leading global pharmaceutical client. The company values diversity of thought and encourages autonomy, making it an ideal place for those looking to make a meaningful impact in the field of clinical trials.
