Job Description

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.

AUTHORITY:

• Select and hire departmental staff, within budgetary constraints and in accordance with company policy.
• Specify the necessary training requirements for Biostatistics staff.
• Specify the roles and responsibilities of the Biostatistics staff.
• Assign Biostatistics resources to project teams according to the applicable process.
• Dismiss a staff member, upon consultation with Human Resources and the Head of Clinical Reporting, and after completing any documentation required by Human Resources.

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.
• Experience with SAS Base and SAS Stat skills.
• Experience with other statistical software packages, such as N-Query, S-Plus.
• 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.
• Previous experience in managing people within a scientific/clinical environment is required.
• Excellent interpersonal and organization skills.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible \xe2\x80\x93 to help our customers create a healthier world. Learn more at

IQVIA