Biostatistician

Summary

Join RQM+, a leading MedTech service provider, as a Biostatistician in the Clinical and Post Market Practice. Collaborate with medical writers and subject matter experts to support regulatory submissions for medical devices. Lead statistical design for post-market clinical activities and analysis. Develop statistical analysis plans and sample size calculations. Provide statistical guidance and expertise for clinical studies. Work closely with data management and study investigators. Stay updated on industry developments and manage resources effectively. This role requires an advanced degree in Biostatistics, relevant experience, and proficiency in statistical software. RQM+ offers an industry-leading compensation package and a focus on work-life balance.

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 Plan for regulatory submission, with strong capability to interact effectively with internal and external teams to address statistical questions related to study design and/or analysis
• Proven track record of success in designing a wide range of clinical studies with various statistical methodology; experience in adaptive design (e.g., sample size re-estimation, Bayesian adaptive design) and using historical control is preferred
• In-depth knowledge and extensive experience of conducting statistical analysis to support the development of clinical study reports
• Proficient in R and/or SAS programming and/or a suitable statistical programming environment
• Able to bridge analytics to clinical interpretation and explain complex mathematical/statistical problems to team members and senior leadership
• Strong knowledge of 21 CFR part 812, Good Clinical Practice, ISO14155 and other regulations/guidelines on clinical research
• Excellent verbal/written communication, presentation, teamwork and interpersonal skills; capability to build strong cross-functional collaboration both internally and externally
• High attention to detail and scientific integrity
• Excellent organizational planning, project management and time management skills

Responsibilities

• Understand the study from the CERs, Study plans and Questioners etc
• 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

Preferred Qualifications

Experience for analysis of a large dataset (administrative or commercial data sets) is desirable

Benefits

• Industry leading compensation package
• Focus on work life balance
• Flexible schedule
• Travel at least 25% of the time