Principal Biostatistician FSP, Late Phase

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 multidisciplinary teams, writing statistical sections of protocols, and authoring analysis plans. The ideal candidate will have a strong background in statistics, with a PhD or MS in a related field and extensive experience in clinical trials. You will play a crucial role in influencing the future of medicine by contributing to regulatory documents and guiding programming efforts. If you are passionate about data and want to make a significant impact in the pharmaceutical industry, this opportunity is for you.

Qualifications

• PhD in Statistics/Biostatistics with 5+ years of experience or MS with 7+ years.
• At least 3 years in Phase 2/3 clinical trial experience.

Responsibilities

• Collaborate with teams to establish project objectives and timelines.
• Write and author statistical analysis plans and trial protocols.

Skills

Statistical Analysis

Clinical Trials

Communication Skills

Project Management

R Programming

SAS

Regulatory Knowledge

Education

PhD in Statistics or Biostatistics

MS in Statistics or Biostatistics

Tools

CDISC Standards

SDTM

ADAM

CDASH

Job description

Job Level: FSP Principal Biostatistician, Late Phase

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 yields all the benefits of working for an industry leading global CRO and 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 pharmaceutical 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.
• Author 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. NDA, DSURs, Briefing Documents, ISS, ISE, etc.
• Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming/validation of tables, listings, and figures.
• Interpret study results and review reports of study results for accuracy.
• Support exploratory analyses.
• Participate in pre-IND or 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 pro-actively and independently.
• Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.
• Ability to use R or SAS 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.
• Experience with CDISC, including SDTM, ADAM, CDASH

Desired Experience:

• Interaction with regulators including Advisory Committee meetings.
• 2+ years of experience with renal therapeutic area.

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