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

Job Summary:

Workfully within the sponsor environment, joining an IQVIA biostatistics team focused on the long-term study efforts for a Global Biopharma company. Be dedicated to this one client. Provide statistical expertise as it relates to the design and statistical analysis of clinical studies, mostly Phase II/III studies. Perform analyses, interpret study results, and collaborate with medical and clinical reporting staff.

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.

• 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.

• 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.

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

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

• 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.

• Demonstrates extensive experience in statistical data analysis of clinical trials (Phase I-III) as well as integrated data analyses of safety and efficacy.

Qualifications:

• MS in Statistics, Biostatistics with 8 years of industry experience as a biostatistician.

• PhD in Statistics, Biostatistics with 5 years of industry experience as a biostatistician.

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

• Experience participating in study design activities is highly preferred.

• Strong understanding of statistical regulatory guidance and standards (e.g., FDA, ICH and GCP), with experience participating in package creation for regulatory submissions.

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

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. 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 $137,100.00 - $233,400.00. 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.