IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, consistency checks, tables, and figures. Communicate with clients regarding study protocol or statistical analysis issues as they arise. Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results. Interpret analyses and write statistical sections of study reports.
Role and Responsibilities:
- Coordinate the development of analysis plans, table shells, programming and table specifications, the production of tables, listings and figures, data review and statistical analysis.
- Perform protocol development, sample size calculation, protocol and CRF review.
- Advise data management staff on database design, validation checks and critical data.
- Write statistical sections of integrated reports.
- Provide expert statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables (i.e. database design, validation checks and critical data).
- Fulfill the Lead role for single complex studies or groups of studies.
- Manage project budget and resource requirements. Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies.
- Perform the review of RFPs and QIPs, prepare proposal text and attend bid defense meetings.
- Manage customer relationships.
- Provide training and guidance to lower level and new staff.
Required Knowledge Skills and Experience:
- Must have good knowledge of SAS Base and multiple statistical procedures in SAS.
- Must have strong knowledge of performing statistical analysis & calculations for clinical research.
- Must have good knowledge of ICH E6, ICH E3, ICH E8, ICH E9 and US FDA requirements for clinical trials.
- Minimum of 10+ years of experience in Biostatistics within the pharmaceutical or medical devices industry
- Effective skills in communication and team collaboration
- Excellent leadership skills in either a project or line management area
- Strong analytical skills and business aptitude
- Proven skills for mentoring and coaching teams
- Sound knowledge of theoretical and applied statistics.
- Extensive experience in clinical trials.
- Comprehensive understanding of regulatory guidelines in a pharmaceutical research setting.
- Ability to effectively collaborate, communicate, and influence throughout all levels of the organization.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE:
- Master's degree in computer science or related field and 3 years relevant experience; Bachelor's degree or educational equivalent in computer science or related field and 5 years relevant experience; or equivalent combination of education, training and experience
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at firstname.lastname@example.org to arrange for such an accommodation.