Senior Biostatistician – FSP
Clinical Outcomes Solutions
full-time
Posted on:
Location Type: Remote
Location: Spain
Visit company websiteExplore more
Job Level
About the role
- 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
- Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices
Requirements
- Master’s 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 is strongly desired.
- Experience in sample size calculation, protocol concept development, protocol development, SAP, and preparing clinical study reports including integrated summaries for submissions.
- Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers. Knowledge of R programming is a plus.
- Solid understanding & implementation of CDISC requirements for regulatory submissions.
- Adept in ADaM specifications generation and QC of datasets.
- The ability to build strong external & internal relationships and motivate a regional or global team.
- Effective communicator: able to explain methodology and consequences of decisions in lay terms.
Benefits
- Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
statistical analysissample size calculationstatistical analysis plans (SAPs)clinical study reportsSAS programmingR programmingADaM specificationsdata validationdata transfer specificationsgood clinical practice
Soft Skills
strong communication skillscollaborationrelationship buildingmotivationeffective communication
Certifications
Master’s degree in statisticsPh.D. in statistics or related discipline