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 client needs, negotiate analysis needs and associated costs.
• Ability to review analysis plans and specifications for completeness and accuracy.
• Excellent written and oral communication skills including grammatical/technical writing skills.
• Ability to synthesize results in graphic, oral, and written reports.
• Experience with SAS Base and SAS Stat skills.
• Demonstrated ability to lead, motivate, and mentor technical staff at a variety of levels.
• Excellent ability to perform multiple tasks effectively and efficiently with minimal supervision while meeting deadlines.
• Knowledge of budget preparation, scheduling, and monitoring.
• Excellent interpersonal skills.
• Ability to communicate effectively, both verbally and in writing, with all levels of staff with clients, and with the public.
• Ability to work creatively and independently to carry out assignments of a complex nature.
• Ability to work effectively and cooperatively with other professional staff members.
• Willingness to learn new methodology, new technology, and new tools that will facilitate the clinical trial process.

MINIMUM RECRUITMENT STANDARDS:

• Degree requirements include one of the following:
  • Masters-level degree in Statistics, Biostatistics, or related field with 11 years relevant CRO or pharmaceutical/biotech/device company experience; or
  • Doctorate-level degree in Statistics, Biostatistics, or related field with 7 years relevant CRO or pharmaceutical/biotech/device company experience. 
• Familiarity with complex statistical methods
• 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
• Working knowledge of relevant Data Standards (such as CDISC/ADaM)
• Previous experience in managing people within a scientific/clinical environment is required.
• Excellent interpersonal and organization skills. 

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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

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