40 applicants

Company

IQVIA · 1 day ago

Senior/Principal Biostatistician, Early Phase (PK/PD)

Durham, NC

Full-time

Remote

Senior Level, Lead/Staff

$131K/yr - $244K/yr

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AnalyticsHealth Care

H1B Sponsor Likely

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Responsibilities

Coordinate the development of analysis plans, table shells, programming and table specifications, the production of tables, listings and figures, data review and statistical analysis.

Perform protocol development, sample size calculation, protocol and CRF review.

Advise data management staff on database design, and critical data. May advise on validation checks.

Write statistical sections of integrated reports.

Provide expert statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables (i.e. database design, validation checks and critical data).

Act as statistical team lead for single complex studies or groups of studies.

Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies. May manage project budget and resource requirements.

Perform the review of RFPs and QIPs, prepare proposal text and attend bid defense meetings.

Manage customer relationships.

Provide training and guidance to lower level and new staff.

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.

Statistical methodsSAS computing packageClinical research regulationsData Standards (CDISC/ADaM)Technical writingProject managementStatistical computing packages

Required

Excellent written and oral communication skills including grammatical/technical writing skills

Excellent attention and accuracy with details

In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

Familiarity with moderately complex statistical methods that apply to applicable clinical trials

Strong individual initiative

Strong organizing skills

Strong working knowledge of SAS computing package

Familiarity with other relevant statistical computing packages such as nQuery

Strong commitment to quality

Ability to effectively manage multiple tasks and projects

Ability to lead and co-ordinate small teams

Ability to solve moderately complex problems

Ability to establish and maintain effective working relationships with coworkers, managers and clients

Working knowledge of relevant Data Standards (such as CDISC/ADaM)

Benefits

Incentive plans

Bonuses

Health and welfare and/or other benefits

Company

IQVIA

Glassdoor

3.9

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

Founded in 1982

Danbury, Connecticut, USA

10001+ employees

https://www.iqvia.com

H1B Sponsorship

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2020 (197)