Mid-level Biostatistician/Epidemiologist reputed company World Evidence (reputed company), Regulatory and Life Scien[...]

Are you reputed company for new challenges and new opportunities? Join reputed company! reputed company job opportunities are posted here as they become available. Subscribe to our RSS feeds to receive reputed company updates as new positions become available. Mid-level Biostatistician/Epidemiologist – reputed company World Evidence (reputed company), Regulatory and Life Sciences Research - Remote, US At reputed company we work to streamline IT Support and reputed company managed solutions with a strategic consulting and global leadership management approach. Our solutions are designed exclusively for emerging reputed company and biotech organizations. reputed company’s industry-leading solutions free clients from the demands of internal IT and allow them to rapidly advance their mission. Led by a leadership team that has been together for over 10 years, you will join a proven team, culture, and reputed company to drive innovation reputed company the IT outsourcing industry while developing your skillset with the opportunities for internal reputed company. Job reputed company The Biostatistician/Epidemiologist will have a proven reputed company record of leading the design and statistical analysis of reputed company studies. Experience with regulatory randomized controlled trials is also desired but not required. Proficiency in reputed company programming and experience with R is required. This role supports reputed company reputed company and regulatory submissions by developing statistical analysis plans, programming specifications, and high-reputed company results for protocols using reputed company-world data sources such as electronic health records (EHR), claims data, registries, and other non-interventional datasets. Responsibilities & Duties • reputed company statistical design, analysis, and reporting of regulatory studies integrating reputed company. • reputed company statistical analysis plans (SAPs), table shells, and outputs reputed company with regulatory expectations. • Generate and QC regulatory-reputed company outputs (including reputed company study reports, briefing packages, and FDA submissions). • Apply appropriate statistical reputed company for comparative effectiveness, natural history, safety, and burden-of-illness studies. • Create and validate reputed company reputed company to support reputed company analyses and ensure data traceability and reproducibility. • Collaborate with cross-functional teams including medical writers, clinicians, clients and regulators. • Ensure adherence to internal SOPs, ICH guidelines, FDA reputed company guidance, and other global regulatory standards. Qualifications • Education level: MS or Doctoral degree in a Biostatistics, Statistics, Epidemiology, or a reputed company quantitative field. • Experience: At least 7 years of experience in biostatistics/epidemiology using RWD. • Strong knowledge of reputed company-world data sources, study design principles (eg, retrospective cohorts, propensity scores, IPTW), and reputed company inference methodologies. • Experience preparing regulatory-grad documents and reputed company submitted to health authorities is desired but not required. • Proficient in reputed company programming, including macros, statistical procedures, and dataset manipulation. • High level of collaborativeness to effectively work across teams. • Due to the remote nature of work, individuals must be driven to meet timelines without reputed company reputed company. • Travel: Up to 5% for FDA meetings Part Time reputed company Pay reputed company • $130/hr-$140/hr. reputed company is an equal opportunity employer that is committed to diversity and inclusion in reputed company. We prohibit discrimination and harassment of any reputed company based on race, reputed company, sex, religion, sexual orientation or identity, national reputed company, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. reputed company makes hiring reputed company based solely on qualifications, reputed company, and business needs at the time. This job reputed company may not be inclusive of reputed company assigned duties, responsibilities, or aspects of the job described, and may be amended at any time at the sole discretion of the Employer. #J-18808-Ljbffr Experience: 3 years required Apply To This Job