FSP Principal Biostatistician- Early Phase Clinical Development(PK) at IQVIA

Durham, North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Clinical ResearchIndustries

Requirements

PhD in Statistics, Biostatistics, or related field or MS in Statistics, Biostatistics, or related field
PhD: 3+ years industry experience or MS: 5+ years of industry experience
Proficiency in SAS and/or R

Responsibilities

Collaborate with multidisciplinary project teams to establish project timelines
Provide statistical input to study synopses and protocols
Write the statistical sections of clinical trial protocols, including sample size calculations, while consulting with internal and external experts
Review eCRF and other data management documents
Create or review randomizations and related specifications
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
Provide statistical review and validation of the same
Use SAS and/or R to perform inferential analyses and validate key data derivations
Interpret study results and review reports of study results for accuracy
Monitor internal and CRO project activities including timelines, deliverables, and availability of resources
Collaborate with Data Management, Clinical Development, and Clinical Pharmacologists/PK with statistical expertise
Contribute to clinical study reports and other regulatory documents e.g., DSURs, IB, etc
Support exploratory analyses
May support IND activities

Skills

SAS

Biostatistics

Pharmacokinetics

Pharmacodynamics

Sample Size Calculations

Statistical Analysis Plans

Clinical Trial Protocols

Randomization

TLF Specifications

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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