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.
*We are looking to hire multiple Therapeutic Area Leads, preferably in Oncology, Gastroenterology and Vaccines. The roles are open to be office or home based.
The role will fulfill a role of Therapeutic Area Lead for a dedicated customer. Provide direction and guidance in carrying out project assignments, interfacing with clients and other internal departments, and applying advanced statistical methods to project work. Serve as a resource for the department, ensuring scientific integrity in the application of statistical methodology to clinical trials. Assist the Director in strategic planning and resource allocation for the department. Participate as senior statistician on major projects, including developing/reviewing protocols, preparing analysis plans, overseeing the conduct of analyses, and preparing integrated clinical and statistical reports. Assist the Director in proposal development, FTE allocation, budget projections, and client presentation, as needed. Conduct independent research and teaches courses in statistical methodology as resources permit.
i) Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the company.
ii) Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact on analyses.
iii) Represent clients at meetings with regulatory agencies or other regulatory meetings; may participate as a member of a Data and Safety Monitoring Committee.
iv) As approved, participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication.
v) May participate as high level lead biostatistician on major project(s) including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, ISSs, ISEs and/or NDA sections, as required.
•Ensure the high quality and timeliness of deliverables from the Biostatistics department. Oversee and ensures the high quality level of the Biostatistics expert review process.
•Participate in project meetings; keep up-to-date on project issues; keep Director informed of project issues.
•Coordinate and participate in process improvements and interoffice/interdepartmental task forces; oversee collection and reporting of Biostatistics metrics, implementation of revised work practices, new guidelines, and new software tools as they become available
•Effectively allocate resources at the site level so as to achieve target utilization rates and project realization rates.
•Assist in the following: (i) sales meetings as required; (ii) overseeing proposal preparation; (iii) ensuring that all proposals bid by the department have an adequate budget, and sufficiently detailed set of budget assumptions.
•May Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Typically requires a minimum of 5 - 7 years of prior experience as a study lead and at least 2 to 3 years direct experience managing a strategic client relationship.
Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one department or multiple related departments.
Biostatistics or related field and 10 years relevant experience including 2 years experience managing staff
Biostatistics or related field and 7 years relevant experience including 2 years experience managing staff
Biostatistics or related field and 5 years relevant experience including 2 years experience managing staff
Skills and Abilities
Familiarity with most 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 Familiarity with moderately complex statistical methods that apply to applicable clinical trials
Strong working knowledge of SAS
Excellent written and oral communication skills with good interpersonal skills
Excellent problem solving skills
Excellent presentation skills
Sound judgment/decision making
Ability to lead and motivate a team
Ability to establish and maintain effective working relationships with coworkers, managers and clients
Working knowledge of relevant Data Standards (such as CDISC/ADaM)
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 email@example.com_ to arrange for such an accommodation.
At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren't just possible - they are expected.
Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you're supported to succeed.