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Principal Biostatistician FSP, Immunology

extra holidays

Remote:

Full Remote

Contract:

Full time

Salary:

131 - 244K yearly

Experience:

Senior (5-10 years)

Work from:

North Carolina (USA), United States

Offer summary

Qualifications:

PhD in Statistics or related field with 5+ years industry experience., MS in Statistics or related field with 7+ years of industry experience., At least 3 years in Phase 2/3 clinical trial experience., Ability to use R for analyses..

Key responsabilities:

Collaborate with project teams on objectives and timelines.
Write statistical sections of clinical trial protocols.

IQVIA Large https://www.iqvia.com/

10001 Employees

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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.

Additional Benefits:

Home-based remote working opportunities
Work/life balance as well as flexible schedules.
Collaborating with motivated, high-performance, statistical and research teams
Technical training and tailored development curriculum
Research opportunities that match your unique skillset
Promising career trajectory
Job stability: long-term engagements and re-deployment opportunities
Focus on bringing new therapies to market rather than project budgets and change orders.
Experience with regulatory submissions.
Engaging, fast-paced environment.
Good work-life balance.

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.
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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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

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

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.