Principal Biostatistician, Fsp

Job Level :

FSP Principal Biostatistician

Location : Home-based in Mexico

Overview

Data Sciences Staffing Solutions, DSSS, is a unit within IQVIA that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership.

This means you get all the benefits of working for an industry leading global CRO while collaborating directly with expert cross-functional sponsor teams.

Sponsor clients include world class pharmaceutical and biotech companies offering you unique opportunities to influence the future of medicine and advance therapies to market.

Job Summary

This FSP Statistician position will provide statistical support for projects within a sponsor development team.

The qualified candidate will collaborate and work closely with project / study teams and provide statistical expertise in designing research concepts, developing protocols, writing statistical analysis plans, performing statistical analyses, interpreting and presenting results, writing / reviewing reports, and publishing manuscripts through co-authorship.

The candidate may also provide support in regulatory submissions including responses to regulatory queries.

A successful candidate will make contributions through quantitative and creative thinking as well as proactively staying in the front of the current development of statistical methodologies.

Responsibilities & Duties

Provide scientifically rigorous statistical input on post-hoc / ad-hoc analysis requests in supporting publication projects and regulatory query responses.

Develop statistical analysis plan, mock-up tables, quality check plan.

Oversee programming support activities for assigned projects.

Validate the accuracy, consistency and integrity of the statistical output displays generated by programmers.

Lead multiple project teams by applying project management skills, statistical and programming techniques to prepare, execute, report, and document of high-quality statistical analysis per statistical analysis plans.

Conduct peer review of project related work performed by other statisticians, maintain compliance with the latest regulatory requirements, maintain project documentation and files according to departmental policy.

Communicate competently and independently with client to coordinate the statistical and programming considerations of the project.

Demonstrate strong understanding of ICH guidelines and clinical trial design, as applicable to statistics.

Basic Qualifications

Masters in Statistics / Biostatistics (or related field) with 7+ years' experience in clinical trials, or 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

Preferred qualifications

Strong computational skills

Experience with different study designs, protocol development, and statistical analysis plan writing

Note

We have Principal Statistician roles across all areas of FSP- Early Phase, Late Phase aligning to various Therapeutic studies.

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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.

We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

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