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IQVIA is hiring for a Principal Biostatistician to join a sponsor-dedicated team. Expect to work fully within the sponsor environment, progressing with long-term study initiatives for late phase activities. Cardiovascular Metabolic therapeutic area. It's required to have extensive experience with Phase II, III clinical trials. In addition, it's expected to have Medical Affairs experience. This role is fully work-from-home. Candidates in the U.S. and Canada can be considered.

Primary Responsibilities:

• Provide statistical expertise for experimental design, descriptive and inferential statistics, and analysis and reporting of clinical research studies.

• Participate in the development and subsequent utilization of statistical tools for conducting meta-analyses of safety data and for benefit-risk analyses.

• Authors or oversees authorship of Statistical Analysis Plans (SAPs) and Statistical Programming Plans (SPPs). Ensure rigorous approaches are taken to ensure good scientific practices as followed: proper statistical methods utilized in analysis plans, and assay methods are appropriately designed, blinded, and randomized to meet objectives.

• Performs exploratory statistical analysis and quantifies the benefits, risks, values and uncertainties of drug research and development to make sound conclusions and propose drug development strategies.

• Develop mock tables, figures, and listings (TFLs) for standard statistical analyses.

• Perform sample size calculations.

• Identifies data or analytical issues and either applies skills and knowledge to solve problems or seeks help to achieve solutions.

• Reviews case report form (CRF) designs to ensure data collection meet the requirements of statistical analyses.

• Provides statistical guidance/oversight to statisticians regarding requirements and GCP standards.

• Makes statistical contributions to clinical study reports, including authoring of statistical methods, data interpretation Clinical Study Reports (CSRs), and manuscripts for publication / presentation.

• Accounts for statistical activities in support of IND/NDA or other regulatory submissions. Address statistical questions/comments from FDA and other regulatory agencies, and review and address comments by IRB/ECs.

Qualifications:

• MS in Statistics, Biostatistics with 7+ years of industry experience.

• PhD in Statistics, Biostatistics with 4+ years industry experience.

• Extensive experience in statistical data analysis of clinical trials (Phase II, III) is required.

• Publications, Medical Affairs experience is expected.

• Efficient in writing and reviewing Statistical Analysis Plan (SAP).

• Experience in statistical programming (SAS and R) and other relevant statistical analysis software systems.

• Strong understanding of statistical regulatory guidance and standards (e.g., FDA, ICH and GCP).

• Authoring of the Statistical Analysis Plan (SAP).

• Experience in oversight of biostatistical programming and data management services.

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.