Principal Biostatistician – Oncology (FSP -Permanent Homebased) at IQVIA

Reading, England, United Kingdom

Apply Now

Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceutical, OncologyIndustries

Requirements

Advanced degree (Master’s or PhD) in Biostatistics, Statistics, or a related field
5+ years of experience in clinical trials, with a strong focus on oncology (hematology and late-phase preferred)
Proven experience working on registrational studies and regulatory submissions
Strong knowledge of CDISC standards, particularly ADaM and SDTM
Proficiency in SAS programming and ability to perform hands-on statistical analyses
Excellent communication skills and ability to work independently in a global, cross-functional environment

Responsibilities

Serve as the lead statistician on global late-phase registration trials, particularly in oncology (hematology preferred)
Independently contribute to study design, statistical analysis plans (SAPs), and regulatory submission strategies
Participate in study team meetings, providing statistical guidance and collaborating with cross-functional teams
Address health authority questions and support responses with appropriate statistical analyses and documentation
Perform hands-on statistical programming to derive outputs and summary statistics using ADaM and SDTM datasets
Ensure timely and accurate delivery of statistical deliverables in compliance with regulatory standards

Skills

Key technologies and capabilities for this role

SASADaMSDTMCDISCBiostatisticsStatistical ProgrammingSAPStudy DesignRegulatory Submissions

Questions & Answers

Common questions about this position

Is this position remote or home-based?

Yes, this is a permanent, home-based position offering the flexibility of remote work.

What are the required qualifications for this role?

Candidates need an advanced degree (Master’s or PhD) in Biostatistics, Statistics, or related field, 5+ years of experience in clinical trials with a focus on oncology (hematology and late-phase preferred), proven experience in registrational studies and regulatory submissions, strong knowledge of CDISC standards (ADaM and SDTM), and proficiency in SAS programming.

What is the salary for this position?

This information is not specified in the job description.

What is the company culture like?

The role offers a collaborative and innovative team environment focused on high-impact global studies in oncology.

What makes a strong candidate for this Principal Biostatistician role?

Strong candidates will have prior involvement in FDA/EMA submissions, experience addressing regulatory agency queries, and familiarity with real-world evidence and observational studies, in addition to the required qualifications.

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.

Land your dream remote job 3x faster with AI

Try Jobo Free