Principal Biostatistician FSP, R Regulatory Submission

IQVIA; Durham (NC); On-site; USD 131,000 - 244,000; Full time

Job summary

An established industry player is seeking a Principal Biostatistician to provide statistical support for clinical trials. In this pivotal role, you will collaborate with cross-functional teams, write statistical sections of clinical trial protocols, and monitor project activities. This position offers the unique opportunity to influence the future of medicine while working with world-class pharmaceutical and biotech companies. If you are passionate about advancing therapies to market and have a strong background in biostatistics, this is the perfect opportunity for you to make a significant impact in the healthcare industry.

Qualifications

• PhD or MS in Statistics/Biostatistics with extensive industry experience.
• 3+ years in Phase 2/3 clinical trial experience is essential.

Responsibilities

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

Skills

Statistical Analysis

Project Management

Communication Skills

R Programming

Clinical Trial Experience

Multiple Imputation Analysis

Education

PhD in Statistics or Biostatistics

MS in Statistics or Biostatistics

Tools

CDISC Standards

Statistical Software (R)

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:

1. Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
2. Write the statistical sections of clinical trial protocols, while consulting with internal and external experts.
3. Write statistical analysis plans.
4. Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
5. Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise.
6. Contribute to clinical study reports and other regulatory documents e.g., DSURs, Briefing Documents, etc.
7. Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings, and figures.
8. Interpret study results and review reports of study results for accuracy.
9. Support exploratory analyses and medical affairs publications.
10. Participate in pre-IND and NDA activities.
11. 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)

1. PhD in Statistics, Biostatistics, or related field with 5+ years industry experience.
2. MS in Statistics, Biostatistics, or related field with 7+ years of industry experience.
3. At least 3 years in Phase 2/3 clinical trial experience.
4. Demonstrated ability to work independently in project management and decision making.
5. Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.
6. Ability to use R to perform efficacy and safety analyses and validate important data derivations when necessary.
7. Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
8. 2+ years supporting multiple imputation analyses.
9. Experience with CDISC, including SDTM, ADAM, CDASH.

Desired Experience:

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

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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.

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

The potential base pay range for this role, when annualized, is $131,300.00 - $243,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

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.

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