Principal Biostatistician FSP, R Regulatory Submission at IQVIA

Durham, North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

PhD in Statistics, Biostatistics, or related field or MS in Statistics, Biostatistics, or related field
PhD: 5+ years of industry experience; MS: 7+ years of industry experience
At least 3 years in Phase 2/3 clinical trial experience
Demonstrated ability to work independently in project management and decision making
Ability to effectively communicate ideas and manage programmers constructively
Proficiency in using R for efficacy and safety analyses and data validation

Responsibilities

Collaborate with multi-disciplinary project teams to establish project objectives and timelines
Write the statistical sections of clinical trial protocols, consulting with internal and external experts
Write statistical analysis plans
Monitor internal and CRO project activities, including timelines, deliverables, and resource availability
Collaborate with Data Management, Clinical Development, and Clinical Operations, providing statistical expertise
Contribute to clinical study reports and other regulatory documents (e.g., DSURs, Briefing Documents, etc.)
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
Support exploratory analyses and medical affairs publications
Participate in pre-IND and NDA activities
Participate in other activities and meetings to support Biostatistics and the Development Team as needed

Skills

Biostatistics

Statistical Analysis Plans

Clinical Trial Protocols

Regulatory Submissions

SAS Programming

R Programming

TLFs

DSURs

NDA

IND

Data Management

Exploratory Analyses

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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