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Company

IQVIA · 4 days ago

Principal Biostatistician FSP, Pharmacokinetics

Durham, NC

Full-time

Remote

Senior Level

$131K/yr - $244K/yr

7+ years exp

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Responsibilities

Collaborate with multidisciplinary project teams to establish project timelines.

Provide statistical input to study synopses and protocols.

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

Write or review statistical analysis plans, dataset and TLF specifications.

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.

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

Collaborates with Data Management, Clinical Development, and Clinical Pharmacologists with statistical expertise.

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

Support exploratory analyses and publications.

Participate in pre-IND and NDA activities.

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

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

Able to effectively communicate statistical concepts to colleagues.

Able to effectively manage CROs.

Use SAS and/or R to perform inferential analyses and validate important data derivations when necessary.

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.

StatisticsBiostatisticsStatistical analysisPKPD endpointsCDISCSASR programmingMultivariate analysesBiomarker analysesICH GCP

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.

3+ years of experience in statistical analysis of PK and PD endpoints in pharmaceutical industry

Understanding of ICH GCP as well as general knowledge of industry practices and standards.

Experience with CDISC, including SDTM, ADaM, CDASH.

Preferred

Familiarity with R programming language and other statistical software, including EAST.

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

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2023 (218)

2022 (199)

2021 (286)

2020 (197)