Principal Biostatistician FSP, R Regulatory Submission

IQVIA Argentina; Durham (NC); Remote; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Principal Biostatistician to provide statistical support for clinical trials. This role involves collaborating with project teams, writing protocols and analysis plans, and guiding programming efforts. The successful candidate will have a strong background in statistics, particularly in clinical trial settings, and will contribute to regulatory submissions. This innovative firm offers a unique opportunity to influence the future of medicine while working with world-class pharmaceutical and biotech companies. If you are passionate about advancing therapies and making a difference, this role is for you.

Qualifications

• PhD or MS in Statistics/Biostatistics with extensive industry experience.
• 5+ years of experience in clinical trials, especially Phase 2/3.

Responsibilities

• Provide statistical support for clinical trials and regulatory submissions.
• Collaborate with multi-disciplinary teams and write statistical analysis plans.

Skills

R Programming

Project Management

Statistical Analysis

Communication Skills

Clinical Trial Experience

Education

PhD in Statistics or Biostatistics

MS in Statistics or Biostatistics

Tools

CDISC Standards

Statistical Software

Job description

Job Level: FSP Principal Biostatistician - R Regulatory Submission and Multiple Imputations

Location: Home-based in the U.S. or Canada

Why DSSS?

Data Sciences Staffing Solutions, DSSS, is a unit within IQVIA that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This means you get all the benefits of working for an industry leading global CRO while collaborating directly with cross-functional sponsor teams. Sponsor clients include world class pharmaceutical and biotech companies offering you unique opportunities to influence the future of medicine and advance therapies to market.

Job Summary:

The Principal Biostatistician is responsible for providing statistical support for clinical trials in patients.

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.
• Participate 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.
• At least 3 years in Phase 2/3 clinical trial 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 R to perform efficacy and safety analyses and validate important data derivations when necessary.
• Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
• 2+ years supporting multiple imputation analyses.
• Experience with CDISC, including SDTM, ADAM, CDASH.

Desired Experience:

• Interaction with regulators including Advisory Committee meetings.
• 2+ years of experience with Immunology therapeutic area and regulatory submissions.

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