Associate Director Biostatistics - (R1026032) in Overland Park, KS at IQVIA™

Date Posted: 5/30/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    At least 5 year(s)
  • Date Posted:
    5/30/2018
  • Job ID:
    R1026032

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Description

PURPOSE
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
 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.

Job Requirements

REQUIRED KNOWLEDGE, 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)
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
 PhD in biostatistics or related field and 5 years relevant experience including 2 years experience managing staff; Master's degree in biostatistics or related field and 7 years relevant experience including 2 years experience managing staff; Bachelor's degree in biostatistics or related field and 10 years relevant experience including 2 years experience managing staff.
 
EEO Minorities/Females/Protected Veterans/Disabled

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.


Job ID: R1026032