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BASIC FUNCTIONS:

Assist with the management, leadership, and training for the Biostatistics department.  Manage staffing of projects and coordinate task assignments.  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:

• Assists with the development of processes, procedures and guidelines relating to biostatistical activities. Oversee departmental SOPs and Working Practices for ongoing accuracy and ongoing process improvement. Assist with the development of templates for efficient programming of data displays and consistent reporting.
• Work with biostatistics management to ensures adequate biostatistical staffing of all project teams and help coordinate resources across the Biostatistics group.  Coordinates tasks and resourcing with the programming department as needed.
• Provides leadership, mentoring, training and statistical support for Biostatistics staff.
• Oversee all biostatistical activities, including statistical analysis plan development, database specification, reporting specification, statistical programming analysis, and statistical summary/report writing.
• Provide statistical consultation for clinical programs.
• Makes presentations to clients and other interested individuals about the processes and procedures of the Clinical Reporting department, and Biostatistics in particular.
• Reviews 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. 
• 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.
• Ability to synthesize results in graphic, oral, and written reports.
• Ability to perform statistics oversight, mentoring and guiding less experienced statisticians (after initially leading a few studies to get a good grounding in processes); able to handle challenging clients; able to support high-level activity such as protocol development and study design/strategy; able to manage / oversee regular study financials.   
• Experience with SAS Base and SAS Stat skills.
• In terms of therapeutic experience, oncology is our highest priority, with CNS and cardiovascular of interest as well. 
• Being a Statistical expertise in a variety of methods we commonly use, and ability to support more advanced methodologies such as MI, Bayesian and/or other adaptive designs/method.
• Demonstrated ability to select, lead, and motivate technical staff.
• 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 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 seven years relevant CRO or pharmaceutical/biotech/device company experience; or
• Doctorate-level degree in Statistics, Biostatistics or related field with five 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

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.https://jobs.iqvia.com/covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $131,300.00 - $243,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.