Principal Biostatistician (FSP - Permanent Homebased)

Nanosep AB; Reading; Remote; GBP 60,000 - 90,000; Full time

Job summary

A leading company seeks a Principal Biostatistician for a permanent home-based position. The role involves collaborating on clinical trial projects, writing protocols, and guiding programming activities. Candidates should have a PhD or MS in relevant fields with substantial industry experience. This position offers competitive remuneration and the opportunity to influence clinical development positively.

Qualifications

• PhD or MS in relevant fields with extensive industry experience.
• Strong early phase experience; Project management skills essential.
• Ability to communicate complex ideas effectively.

Responsibilities

• Collaborate with project teams to establish objectives and timelines.
• Write statistical sections and analysis plans for clinical trials.
• Monitor project activities including timelines and deliverables.

Skills

Statistical analysis

Project management

Communication

SAS

R programming

Education

PhD in Statistics, Biostatistics, or related field

MS in Statistics, Biostatistics, or related field

Tools

SAS

R programming

Job description

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Job Responsibilities

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

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

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled

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Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

• Industries

  IT System Data Services

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