Associated Director, Biostatistics (R1110185) in Durham, NC at IQVIA™

Date Posted: 1/6/2020

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Durham, NC
  • Experience:
    Not Specified
  • Date Posted:
    1/6/2020
  • Job ID:
    R1110185

Job Description

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.

JOB OVERVIEW

Job Profile Summary

Manage a team of Biostatistics staff. May fulfill the role of site head or functional head within a site.  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.

Responsibilities

Essential Functions

•Technical responsibilities:

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.

•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.

•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.

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.

Experience

Typically requires a minimum of 5 - 7 years of prior relevant experience.

Knowledge

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

Education

Bachelor's Degree

Biostatistics or related field and 10 years relevant experience including 2 years experience managing staff

Or

Master's Degree

Biostatistics or related field and 7 years relevant experience including 2 years experience managing staff

Or

Ph.D.

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)

Join Us

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 workday_recruiting@iqvia.com to arrange for such an accommodation.



Job ID: R1110185