Director / Associate Director Biostatistics - RWE (Home or Office-based).
Location: Cambridge, Massachusetts
Posted: December 06, 2017
Reference ID: 1724272
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.
Manage a department of Biostatistics and Statistical Programming staff ensuring that target productivity (FTE, utilization, and output) levels are met. May fulfill the role of site head or functional head within a site.
Manage direct personnel reports typically consisting of Manager to Associate Director level staff from each function.
Participate in sales meetings as required and oversees departmental proposal preparation.
Monitor budget and scope of within-office projects and take action necessary to maximize realization.
Ensure that departmental staff contribute to intra- and interdepartmental process improvement to achieve 'best practices'.
Ensure that appropriate levels of professional development and training are provided to staff.
Serve as a biostatistical resource for the department, ensuring scientific integrity in the application of statistical methodology to clinical trials.
Provide statistical direction, technical oversight, or consultancy on major projects or on projects involving particularly complex statistical analyses. Represent clients at FDA or other scientific meetings as required.
• 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.
vi) 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.
vii) 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.
viii) Effectively monitor departmental budget, scope of work, and project risks for all office projects. Participate in monthly project review and operations meetings. Evaluate projects for unsigned contracts or out of scope requests.
ix) Ensure departmental involvement 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.
x) Allocate resources at the site level and assist in resource allocation across Bios sites to ensure so as to achieve target utilization rates and project realization rates.
xi) Take a leadership role in sales meetings as required; oversee proposal preparation; ensure that all proposals bid by the department have an adequate budget, and sufficiently detailed set of budget assumptions. May act as a 'Customer Relationship Manager' for key Accounts.
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
• Excellent written and oral communication skills with excellent interpersonal skills
• Excellent problem solving skills
• Excellent presentation skills
• Excellent judgment/decision making
• Leadership and line management skills
• Some demonstrated success of operation within senior/executive management teams
• 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 7 years relevant experience including 4 years experience managing staff; Master's degree in biostatistics or related field and 8 years relevant experience including 4 years experience managing staff; Bachelor's degree in biostatistics or related field and 12 years relevant experience including 4 years experience managing staff; or equivalent combination of education, training and experience
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™.