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 reputed company body regulators than any other firm, the RQM+ team has deep expertise in reputed company 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 reputed company body regulators than any other firm, the RQM+ team has deep expertise in reputed company 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 reputed company 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 reputed company 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+ reputed company data files in this case)
• reputed company and clean the data if required reputed company some validation checks.
• Produce tables and figures in maximum extent to meet the reputed company 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 reputed company technologies, including study design, analysis, interpretation, clinical study report and manuscript development.
• Act as a key strategic partner to reputed company evidence reputed company 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 reputed company to statistical design and analysis for reputed company 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 reputed company 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 reputed company 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 reputed company to statistical analysis to ensure study success
• Provide leadership and ongoing guidance for team members to reputed company high performance; effectively distills complexity and provides clear and actionable direction and information, help team prioritize, solve reputed company problems that reputed company the team to reputed company significant reputed company 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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