Be an early applicantLess than 25 applicants

Company

IQVIA · 16 hours ago

Associate Biostatistics Director

Durham, NC

Full-time

Remote

Entry, Mid, Senior Level, Lead/Staff, Director/Executive

$131K/yr - $244K/yr

5+ years exp

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Responsibilities

Assist with the management, leadership, and training for the Biostatistics department.

Manage staffing of projects and coordinate task assignments.

Responsible for the quality and completion of projects within Biostatistics.

Help to ensure growth of revenues and profitability through design and implementation of cost-effective processes and positive client interactions.

Perform the duties of Principal/Sr. Biostatistician for projects as needed.

Provides hand-on statistical oversight for clinical trials, including: Support and mentor lead statistician.

Perform senior level review of biostatics deliverables, including statistical analysis plan and TLF Shells development, database specification, reporting specification, statistical programming analysis, and statistical summary/report writing.

Support financial monitoring and oversight.

Evaluate statistical methods appropriate to the study protocol and endpoints.

Support project team in managing client-related challenges and negotiations.

Provides leadership, mentoring, training, and statistical support for Biostatistics staff.

Serve as lead statistician for one or more clinical trials, including: client interface, development of SAP and TLF shells; development/review of specifications; review and delivery of statistical analyses.

Provide statistical consultation for clinical programs.

Support high-level activity such as protocol development, study design and strategy.

Reviews the Biostatistics and Statistical Programming sections of proposal budgets and text.

Participate in client presentations and discussions of IQVIA Biotech services, including preparation and presentation of business development materials and audits.

Assist with management of Biostatistics departmental growth, quality, and profitability.

Show initiative and vision with respect to managing clients and staff to ensure on-time, on-budget deliverables.

Perform other duties that may be requested by management as applicable.

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.

BiostatisticsStatistical programmingSASCDISC SDTMCDISC ADaMGCPICH guidelinesStatistical analysisOncology experienceStatistical expertiseCNS experienceCardiovascular experienceBudget preparationData managementMentoring

Required

Masters-level degree in Statistics, Biostatistics, or related field with seven years relevant CRO or pharmaceutical/biotech/device company experience; or Doctorate-level degree in Statistics, Biostatistics, or related field with five years relevant CRO or pharmaceutical/biotech/device company experience.

Knowledge of the biostatistics, programming, and data management aspects of the pharmaceutical, biotechnology, device, and/or clinical research service industries.

Good working knowledge of CDISC SDTM and ADaM.

Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research.

Experience with the management and statistical analysis of data obtained from clinical trials.

Statistical expertise in a variety of advanced methodologies used in clinical trials, such as: survival analysis; multiple imputation; generalized linear models; Bayesian and/or other adaptive designs/methods; estimand framework.

In-depth therapeutic experience, including expertise in endpoints and complex analytical methods, in areas such as oncology, cardiovascular, dermatology, and/or CNS.

Ability to manage client relationships, establish realistic expectations, evaluate and propose strategies that meet client needs, negotiate analysis needs and associated costs.

Ability to review analysis plans and specifications for completeness and accuracy.

Ability to synthesize results in graphic, oral, and written reports.

Experience with SAS Base and SAS Stat skills.

Demonstrated ability to lead, motivate, and mentor technical staff at a variety of levels.

Excellent ability to perform multiple tasks effectively and efficiently with minimal supervision while meeting deadlines.

Knowledge of budget preparation, scheduling, and monitoring.

Excellent interpersonal skills.

Ability to communicate effectively, both verbally and in writing, with all levels of staff with clients, and with the public.

Ability to work creatively and independently to carry out assignments of a complex nature.

Ability to work effectively and cooperatively with other professional staff members.

Willingness to learn new methodology, new technology, and new tools that will facilitate the clinical trial process.

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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Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2023 (218)

2022 (199)

2021 (286)

2020 (197)