IQVIA · 1 day ago
Senior Biostatistician FSP, Late Phase
Durham, NC
Full-time
Remote
Mid, Senior Level
$116K/yr - $193K/yr
5+ 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 or reviews 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.
Effectively manage internal and CRO project activities including timelines, deliverables, and availability of resources.
Collaborates with Data Management, Statistical Programming and Clinical Development, with statistical expertise.
Use SAS and/or R to perform inferential analyses and validate important data derivations.
Support exploratory analyses and publications.
Contributes to clinical study reports and other regulatory documents e.g., DSURs, Briefing Documents, Benefit-Risk analyses, IB, etc.
Participate in NDA and related activities.
Participates in activities and meetings to support Biostatistics and the Development Team.
Demonstrated ability in working independently, project management and decision making.
Able to effectively communicate statistical concepts.
Compliance with SOPs and best practices to ensure quality work product.
Qualification
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Required
PhD in Statistics, Biostatistics, or related field with 3+ years industry experience.
MS in Statistics, Biostatistics, or related field with 5+ years of industry experience.
Understanding of ICH and FDA Guidance 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.
Experience in a range of therapeutic areas.
Production programming of statistical outputs.
Regulatory submission activities.
Estimand framework.
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
IQVIA provides analytics, compliance, and management solutions to the life sciences industry.
10001+ employees
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)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (218)
2022 (199)
2021 (286)
2020 (197)
Funding
Current Stage
Public CompanyTotal Funding
$1.5B2023-11-14Post Ipo Debt· $500M
2023-05-18Post Ipo Debt· $1B
2019-08-08Post Ipo Equity
Leadership Team
Chris Colapietro
Vice President, Customer Engagement
Christina Bodurow
Vice President, Global Regulatory Affairs
Recent News
2024-12-05
2024-10-31
Company data provided by crunchbase
