Biostatistician Contractor

RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies. RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines in Healthcare products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. In addition to early- and mid-stage MedTech companies, we currently work with 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies. As a biostatistician within the Clinical and Post Market Practice at RQM+, this role will collaborate with medical writers and subject matter experts to support regulatory submissions for medical devices. The role will be responsible for leading statistical design for post market clinical activities and analysis. This role is also responsible for developing statistical analysis plans, sample size calculations, provide materials and guidance to other team members to interface and support manufacturers in clinical data collection. Responsibilities:

• Understand the study from the CERs, Study plans and Questioners etc. then
• Data captured (Raw, Summary and Summary+ excel data files in this case)
• Check and clean the data if required perform some validation checks.
• Produce tables and figures in maximum extent to meet the achieve planned objectives.
• Generate statistical report and presentation for client delivery.
• Responsible for providing statistical guidance and expertise for clinical studies (premarket and post market) across various Intuitive technologies, including study design, analysis, interpretation, clinical study report and manuscript development.
• Act as a key strategic partner to develop evidence generation strategy
• Responsible for developing Statistical Analysis Plan, Post Market Activity Presentation Materials, Providing Initial Interpretations of Results
• Responsible for providing statistical expertise for addressing regulatory authority questions related to statistical design and analysis for all pre-market clinical studies and post market studies/ post-market clinical follow up studies which are overseen by regulatory authorities
• Responsible for conducting data analysis to support the development of Clinical Study Report, Clinical Evaluation Report, conference or journal publications, and other regulatory submission as needed
• Represent the Biostatistics function within the cross-functional teams, collaborate with other team members for the development of Clinical Investigational Plan, Clinical Study Report, Case Report Form, and other key study documents
• Work closely with Data management to define edit specifications and critical variable lists, support data cleaning activities to ensure collection of high-quality data; handles database lock and unblinding process per study requirements
• Build strong relationships with study investigators and key opinion leaders to identify the publication needs; work closely with internal/external authors to develop manuscript, abstract/presentation, or poster, and provide statistical support throughout the publication process
• Stay abreast of latest industry and academic developments in Statistics and modeling techniques and apply adapting methodology to solve unique or challenging study design and statistical analysis issues
• Responsible for managing resource (internal and external) and budget related to statistical analysis to ensure study success
• Provide leadership and ongoing guidance for team members to achieve high performance; effectively distills complexity and provides clear and actionable direction and information, help team prioritize, solve complex problems that enable the team to make significant progress Requirements:
• Advanced degree in Biostatistics or Statistics (Master or Ph. D) with sound knowledge of theoretical and applied statistics
• A minimum of 2-8 years of clinical research biostats working experience in biotech industry (medical device company experience is preferred)
• Extensive experience in the development of Statistical Analysis Pl

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