Be an early applicantLess than 25 applicants

Company

IQVIA · 4 days ago

Principal Biostatistician FSP, Immunology

Durham, NC

Full-time

Remote

Senior Level

$131K/yr - $244K/yr

7+ years exp

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Responsibilities

Collaborate with multi-disciplinary project teams to establish project objectives and timelines.

Write the statistical sections of clinical trial protocols, while consulting with internal and external experts.

Write statistical analysis plans.

Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.

Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise.

Contribute to clinical study reports and other regulatory documents e.g., DSURs, Briefing Documents, etc.

Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings, and figures.

Interpret study results and review reports of study results for accuracy.

Support exploratory analyses and medical affairs publications.

Participate in pre-IND and NDA activities.

Participates in other activities and meetings to support Biostatistics and the Development Team as needed.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

StatisticsBiostatisticsEarly phase experienceImmunology studiesSASR programmingICH GCPCDISCRegulatory submissionsStatistical analysis plansData management collaborationSimulationsMultivariate analysesBiomarker analysesProject management

Required

PhD in Statistics, Biostatistics, or related field with 5+ years industry experience.

MS in Statistics, Biostatistics, or related field with 7+ years of industry experience.

At least 4 years in early phase experience and immunology-related studies in patients.

Demonstrated ability to work independently in project management and decision making.

Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.

Ability to use SAS and/or R to perform efficacy analyses and validate important data derivations when necessary.

Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards.

Experience with CDISC, including SDTM, Adam, CDASH.

1+ years with regulatory submissions.

Preferred

Familiarity with R programming language and other statistical software.

Knowledge of simulations, multivariate analyses, and biomarker analyses.

Benefits

Home-based remote working opportunities

Work/life balance as well as flexible schedules.

Collaborating with motivated, high-performance, statistical and research teams

Technical training and tailored development curriculum

Research opportunities that match your unique skillset

Promising career trajectory

Job stability: long-term engagements and re-deployment opportunities

Focus on bringing new therapies to market rather than project budgets and change orders.

Experience with regulatory submissions.

Engaging, fast-paced environment.

Good work-life balance.

Company

IQVIA

Glassdoor

3.9

IQVIA provides analytics, compliance, and management solutions to the life sciences industry.

Founded in 1982

Danbury, Connecticut, USA

10,001+ employees

https://www.iqvia.com

H1B Sponsorship

IQVIA has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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Trends of Total Sponsorships

2023 (218)

2022 (199)

2021 (286)

2020 (197)