RQM+
Regulatory for Medical Device • Quality Systems for Medical Device • Design Assurance for Medical Device • Product Quality for Medical Device • Post-Market Surveillance for Medical Device
Biostatistician - Contractor
2 days ago
RQM+
Regulatory for Medical Device • Quality Systems for Medical Device • Design Assurance for Medical Device • Product Quality for Medical Device • Post-Market Surveillance for Medical Device
Description
• 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. • Collaborate with medical writers and subject matter experts to support regulatory submissions for medical devices. • Responsible for leading statistical design for post market clinical activities and analysis. • Developing statistical analysis plans, sample size calculations, and provide materials and guidance to other team members to interface and support manufacturers in clinical data collection.
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. • Experience for analysis of a large dataset (administrative or commercial data sets) is desirable. • 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.
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