Principal Biostatistician (FSP - Permanent Homebased)

IQVIA; Reading; On-site; GBP 45,000 - 65,000; Full time

Job summary

A global leader in clinical research services is seeking a Senior Biostatistician to spearhead statistical analysis in clinical trials. This role involves collaborating with diverse teams to write protocols, oversee project timelines, and ensure analysis accuracy. Ideal candidates will possess a PhD or MS in relevant fields along with substantial experience in industry practices and statistical software.

Qualifications

• PhD with 5+ years or MS with 7+ years of industry experience.
• 1+ years with regulatory submissions.
• Experience with CDISC, SDTM, Adam, CDASH.

Responsibilities

• Collaborate with project teams to establish objectives and timelines.
• Write statistical sections of trial protocols and analysis plans.
• Monitor project activities and contribute to study reports.

Skills

Statistical analysis

Project management

SAS

R programming

Communication

Education

PhD in Statistics, Biostatistics, or related field

MS in Statistics, Biostatistics, or related field

Tools

SAS

R

CDISC

Job description

Job Responsibilities:

· Collaborate with multi-disciplinary project teams to establish project objectives and timelines.

· Write the statistical sections of clinical trial protocols, while consulting with internal and external experts.

· Write statistical analysis plans.

· Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.

· Collaborate with Data Management, Clinical Development, and Clinical Operations with 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.

· Participates in other activities and meetings to support Biostatistics and the Development Team as needed.

Qualifications (Minimal acceptable level of education, work experience, and competency)

· PhD in Statistics, Biostatistics, or related field with 5+ years industry experience.

· MS in Statistics, Biostatistics, or related field with 7+ years of industry experience.

· Strong early phase (Phase I) experience .

· Demonstrated ability to work independently in project management and decision making.

· Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.

· Ability to use SAS and/or R to perform efficacy analyses and validate important data derivations when necessary.

· Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards.

· Experience with CDISC, including SDTM, Adam, CDASH

· 1+ years with regulatory submissions

Desired Experience:

· Familiarity with R programming language and other statistical software.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com