Location

Home-based in the U.S. or Canada

Job Overview:

Work fully within the sponsor environment, joining our team dedicated to the long-term study efforts of a Global Biopharma company. Operate as a Compound Lead for Rare Disease (Hematology). Apply advanced statistical methods to project work and ensure scientific integrity in the application of statistical methodology to clinical trials. Assist the Director in strategic planning and resource allocation for the department. Participate by offering oversight across studies. Will be involved in submissions, study design and strategic planning.

Job Expectations:

• Lead components of statistical contribution to a clinical development program.

• Implements the statistical strategics for the clinical trials and regulatory submissions with the program and is accountable for the statistical deliverables.

• Input to statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions.

• Lead components and fully support conduct in study design, protocol development, data collection, data analysis, report and submission preparation.

• Author the initial SAP for clinical trials and regulatory submissions. Be accountable for timely completion and quality of the SAP.

• 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.

• Be accountable for the TLF/CDISC package for study report and regulatory submission.

• 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 8 years of experience as a biostatistician OR Master's level with 11 years of experience as a biostatistician in clinical drug development.

• Requires practical knowledge in leading and managing the execution of processes, projects, and tactics within one department or multiple related departments.

• Experience in the study design and strategic planning of a study is required.

• Bayesian design and China Submission experience are a plus.

• Experience with complex statistical methods that apply to Phase I-IV clinical trials.

• In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Strong working knowledge of SAS.

Join IQVIA to see where your skills can take you:

• Global exposure

• Variety of therapeutic areas

• Collaborative and supportive team environment

• Access to cutting-edge and innovative, in-house technology

• Excellent career development and progression opportunities

• Work-Life Balance, with a strong focus on a positive well-being

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.