Sr. Biostatistician (Office/Home-Based) - IQVIA Biotech North America

IQVIA Biotech is seeking a Principle Biostatistician with extensive experience (8+ years) leading studies in in a CRO or pharmaceutical setting preferred.

BASIC FUNCTIONS:

Provide statistical expertise and leadership to project and analysis team in one of the following areas: program lead over several studies, expertise in the analysis of data from a certain therapeutic area, expertise in a specific type of statistical analysis.  Provide statistical consulting and technical support as it relates to the design and statistical analysis of clinical studies.  Perform analyses, interpret study results, and collaborate with medical and Clinical Reporting staff to produce interim reports, final reports, and presentations. 

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Collaborate with internal program staff and sponsors on the implementation and analysis of statistical aspects of research protocols.
• Provide statistical consultation for clinical programs, including but not limited to protocol development, randomization, sample size assessments, efficacy evaluations, and data review.
• Define and manage project timelines for specific projects, and ensure that project timelines are met for both internal and external clients.
• Ensure that project tasks are completed with superior quality for both internal and external clients.
• Review, approve and develop, as needed, the statistical analysis summary and analysis plans, including textual description of planned analysis and mock-ups of data displays.
• Oversee and/or perform statistical analyses, including hypothesis testing and modeling.
• Interact with Medical Writers to ensure appropriateness of data inferences and/or write pertinent sections of a clinical study report.
• Interface with clients and/or regulatory agencies as the project biostatistician.
• Ability to oversee a program of studies.
• Assist the Manager and Sr. Director in defining and maintaining departmental standards, SOPs and working practices.
• Provide leadership, mentoring and statistical support for Biostatistics staff.
• Assist the Manager and Sr. Director in development of training materials and execution of training in Biostatistics and general Clinical Reporting activities, for new and existing Clinical Reporting staff.
• Make presentations to clients and other interested individuals about the processes and procedures of the Clinical Reporting department.
• Assist the Manager in the coordination of project tasks and resources across the Biostatistics group, and act as backup during the Manager’s absence, as assigned.
• Perform other duties as assigned.

KNOWLEDGE, SKILLS AND ABILITIES:

• Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research.
• Advanced knowledge of statistical methods used in the design and analysis of Phase I – IV clinical trials.
• Experience with SAS Base and SAS Stat.
• Experience with other statistical software packages, such as N-Query, S-Plus.
• Ability to work creatively and independently to carry out assignments of a complex nature.
• Must be skilled in effective time management.
• Ability to work effectively and cooperatively with other professional staff members.
• Ability to communicate effectively, both verbally and in writing, with all levels of staff and with the public.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

• Very limited physical effort required to perform normal job duties.

MINIMUM RECRUITMENT STANDARDS:

Degree requirements include one of the following:

• Masters-level degree in Statistics, Biostatistics or related field with eight  years relevant CRO industry or biotech experience; or
• Doctorate-level degree in Statistics, Biostatistics or related field with six years relevant CRO industry or biotech experience. 

• Data handling and analysis experience. 
• Excellent interpersonal and organization skills. 

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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 – to help our customers create a healthier world.  https://

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