Principal Biostatistician

IQVIA ,
Stevenage, Hertfordshire
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Job Description

IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. External Job Description IQVIA Biotech has an exciting position within its New EU Biostats team. As the Biotech and Emerging Biopharma arm of IQVIA we are setting up a new department in the EU as we continue to grow and win new business. Historically IQVIA Biotech focused on Oncology, Dermatology and Medical Device studies but with the addition of CNS, Immunology and Cardiovascular we have a need for a strong Lead Statistician. We're looking for enthusiastic and independent professionals with great communication skills who are willing to work from home with an international team. This is the perfect opportunity to join a department as the first in a region and develop leaderships skills. IQVIA Biotech specialises in working with smaller biotech and emerging biopharma clients and as such we have a vibrant, fast-paced work environment. You'll be working with a lot of the new innovative and upcoming research groups across a variety of therapy areas. **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. _Join Us_ Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning. At IQVIA, we have a vision. Where every

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