Advisors Manager – Monitoring, Learning and Evaluation
Evidence Action
Principal Biostatistician
IQVIA
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇲🇽 Mexico
Visit company websiteJob Level
Lead
About the role
- Provide statistical support for projects within a sponsor development team
- Collaborate and work closely with project/study teams and provide statistical expertise in designing research concepts and developing protocols
- Write statistical analysis plans (SAPs), perform statistical analyses, interpret and present results
- Write/review reports and publish manuscripts through co-authorship
- Provide support in regulatory submissions including responses to regulatory queries
- Provide scientifically rigorous statistical input on post-hoc/ad-hoc analysis requests supporting publication projects and regulatory query responses
- Develop statistical analysis plan, mock-up tables, quality check plan
- Oversee programming support activities and validate accuracy, consistency and integrity of statistical outputs generated by programmers
- Lead multiple project teams applying project management, statistical and programming techniques to prepare, execute, report and document high-quality analyses
- Conduct peer review of project related work performed by other statisticians and maintain compliance with regulatory requirements
- Communicate independently with client to coordinate statistical and programming considerations of the project
- Demonstrate strong understanding of ICH guidelines and clinical trial design, as applicable to statistics
Requirements
- Masters in Statistics/Biostatistics (or related field) with 7+ years’ experience in clinical trials
- PhD in Statistics/Biostatistics (or related field) with 5+ years’ experience in clinical trials
- Effective verbal and written communication skills
- Understanding of broad statistical theory and its application
- Able to fully understand clinical questions and concepts and to translate and simplify them into SAP development followed by data generation all the way through publication
- Effective at clearly explaining statistical concepts to colleagues without statistical training
- Work collaboratively as a team member
- Experience with statistical modelling of clinical data and statistical inference
- Experience in R or SAS programming languages
- Based in a time zone within the United States or Europe (UTC-8 to UTC+1) to facilitate real-time collaboration
- Strong computational skills (preferred)
- Experience with different study designs, protocol development, and statistical analysis plan writing (preferred)
- Demonstrated understanding of ICH guidelines and clinical trial design
Benefits
- Home-based / remote work
- Unique opportunities to influence the future of medicine and advance therapies to market
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
statistical analysisstatistical modelingstatistical inferenceR programmingSAS programmingstatistical analysis plan (SAP) developmentdata generationquality check planregulatory submissionspeer review
Soft skills
effective communicationcollaborationproject managementindependent communicationexplanation of statistical conceptsteamworkproblem-solvingattention to detailleadershipadaptability
Certifications
Masters in StatisticsMasters in BiostatisticsPhD in StatisticsPhD in Biostatistics
