Biostatistics Director

BASIC FUNCTIONS:

Provide statistical expertise to IQVIA clients and to the Biostatistics department. Assist with the management, leadership, and training for the Biostatistics department. Responsible for the quality and completion of projects within Biostatistics. Help to ensure growth of revenues and profitability through design and implementation of cost-effective processes and positive client interactions. In addition, perform the duties of Principal/Sr. Biostatistician for projects as needed. This position sits under IQVIA Biotech division of our Business.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Provide statistical consultation for clinical programs, including study design and strategy.
• Support high-level statistical activity, including protocol development / review; sample size / power estimation; preparation of analysis plans; and writing sections of joint clinical/statistical reports, integrated summaries and/or New Drug Application (NDA) sections, as required.
• Provides hand-on statistical oversight for clinical trials, including:
  • Support and mentor lead statistician.
  • Perform senior level review of biostatics deliverables, including statistical analysis plan and TLF Shells development, database specification, reporting specification, statistical programming analysis, and statistical summary/report writing.
• Evaluate statistical methods appropriate to the study protocol and endpoints.
• Support project team in managing client-related challenges and negotiations.
• Represent clients at meetings with regulatory agencies or other regulatory meetings.
• Provide leadership, mentoring, training, and statistical support for Biostatistics staff.
• Support financial monitoring and oversight.
• Review the Biostatistics and Statistical Programming sections of proposal budgets and text.
• Participate in client presentations and discussions of IQVIA Biotech services, including preparation and presentation of business development materials and audits. 
• Assist with management of Biostatistics departmental growth, quality, and profitability.
• Show initiative and vision with respect to managing clients and staff to ensure on-time, on-budget deliverables.
• Perform other duties that may be requested by management as applicable.

KNOWLEDGE, SKILLS AND ABILITIES:

• Knowledge of the biostatistics, programming, and data management aspects of the pharmaceutical, biotechnology, device, and/or clinical research service industries.
• Good working knowledge of CDISC SDTM and ADaM
• Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research.
• Experience with the management and statistical analysis of data obtained from clinical trials.
• Statistical expertise in a variety of advanced methodologies used in clinical trials, such as: survival analysis; multiple imputation; generalized linear models; Bayesian and/or other adaptive designs/methods; estimand framework.
• In-depth therapeutic experience, including expertise in endpoints and complex analytical methods, in areas such as oncology, cardiovascular, dermatology, and/or CNS
• Ability to manage client relationships, establish realistic expectations, evaluate and propose strategies that meet …