Senior Stadistical Consultant, Observational Studies

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

IQVIA™ Real-World Evidence (RWE) teams work with clients to help them collect and use real-world data to generate evidence to meet the needs of regulators, payers, providers and patients. Our approach is unique in the industry and is defining the way companies can develop and apply real-world evidence to provide deeper insight about market dynamics, therapy area changes, outcomes research and other scientific insights. We are collaborative, intellectually curious, entrepreneurial and constantly looking for opportunities to harness the value of real-world evidence in a constantly evolving industry.

Role Purpose
Take responsibility as statistical lead for national and international non-interventional multi-country projects, providing support to the study team. You will provide support in all study steps, starting at time of proposal or protocol development, and ending with the communication of study results (clinical study report or publications in journal or scientific congresses), also including the statistical analysis. Statistical role also includes provide statistical support to other study members. 

Key Responsibilities

• Provide support for proposal development (sample size calculations, statistical methods, study design considerations,…)

• Prepare and being responsible for the statistical aspect of the study protocol, including discussion with client and steering committee members (if required)

• Review the CRF to ensure alignment with the study protocol and ensure that data collected is aligned with planned analysis

• Develop the statistical analysis plan and discuss with clients and other stakeholders, if required

• Provide statistical support during data collection for data review meetings.  

• Perform the statistical analysis defined in the SAP

• Contribute to the preparation of the clinical study report and publications/communications ensuring the statistical aspects

• Attend client and other external meetings in the home base country and elsewhere in Europe and the US to discuss statistical aspects of projects, when required

• Make oral presentations of own research / analysis to clients

• Detect possible deviations or problems during the study design on fieldwork that can impact on the study results and find best solution

• Participate in customers and investigators meetings

• Work within Quality Assurance SOP’s; follow up SOP’s, attend training, participate in internal and external audits, support SOP’s update to Quality Assurance

• Support proposal development

Experience, Qualifications and Skills

• Degree in statistics, mathematics or similar

• At least 5 relevant year experience working in the statistical analysis / planning in observational studies

• Ability to perform the statistical analysis using SAS and R

• Epidemiological knowledge to provide support in the study design phase of the study, as well as to identify potential biases and provide most appropriate solutions from an statistical / epidemiological point of view

• Experience of working in sizable/multi-disciplined teams 

• Must be organized with strong capability in managing projects and juggling priorities so that deadlines are met while retaining consistently high quality outcomes 

• Must be fluent in English, with excellent communication skills (both written and verbal) and strong client influencing skills 

• Ability to liaise comfortably with regulatory authorities, investigators and other study groups

• Demonstrable analytical, interpretative and problem-solving skills

• Flexible approach, prepared to adapt and reprioritize to meet clients and internal needs

• You are a pro-active and stress resistant with an eye for detail and work accurately.

• Strong desire to learn new skills to meet business demands

• High level of literacy – able to appraise evidence critically and write reports and manuscripts in clear, concise language as required by the type of work.

• Good team-based interpersonal skills but also an ability to work independently

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At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.