RQM+ · 1 day ago
Biostatistician Contractor
United States - Remote
Contract
Remote
Entry, Mid Level
2+ years exp
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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
Qualification
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Required
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
Extensive experience in the development of Statistical Analysis Plan for regulatory submission
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
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
High attention to detail and scientific integrity
Excellent organizational planning, project management and time management skills
Willingness to work a flexible schedule and travel at least 25% of the time
Preferred
Medical device company experience
Experience in adaptive design (e.g., sample size re-estimation, Bayesian adaptive design) and using historical control
Experience for analysis of a large dataset (administrative or commercial data sets)
Company
RQM+
RQM+ is a medical device company providing medical device and post-market surveillance services.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Linden Capital Partners
2021-08-16Private Equity
Leadership Team
John Potthoff
Chief Executive Officer
Steven Pilewski
Chief Operating Officer
Recent News
2024-10-28
2024-05-24
Transcontinental Times
2024-05-24
Company data provided by crunchbase
