Summary: Make a significant impact on study success for a biopharma company. Join our sponsor-dedicated biostatistics team to work fully within the sponsor environment, progressing with internal study initiatives over the years. Oncology therapeutic area, involvement in Phase I, II and III studies.

Job Level: Principal Biostatistician or Associate Director, Biostatistics

Location: Home-based

Job Expectations:

• Input to statistical strategy, lead components and fully support conduct in study design, protocol development, data collection, data analysis, report and submission preparation.

• 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.

• Support biostatistics interactions with regulatory authorities (FDA, EMA, PMDA).

• Ensure timeliness and quality of deliverables by external vendors; conduct reviews of deliverables to ensure quality.

• Act as a Thought Partner for innovative study design and clinical development plans.

• Support or lead improvement initiatives within the department and organization.

Qualifications:

• PhD with 5+ years of industry experience or MS with 8+ years of industry experience as a Biostatistician.

• Experience providing statistical leadership at a study level.

• Demonstrated statistical contributions in facilitating and optimizing clinical development.

• Experience supporting regulatory interactions or submissions is preferred.

• Expertise in statistical methodologies in the context of clinical development.

• Good working knowledge in SAS and/or R.

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

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

Colorado/California/Washington state Pay Transparency : The salary range for this role is $137,100 - $185,200.The actual salary will vary based on factors like candidate qualifications and competencies. Certain roles are eligible for annual bonus, sales incentives and/or stock. Benefits may include healthcare, retirement, paid time off, and more.

New York City Pay Transparency : The salary range for this role is $137,100 - $185,200.The actual salary will vary based on factors like candidate qualifications and competencies.