reputed company Biostatistician FSP, Early Phase

reputed company Biostatistician FSP, Early Phase reputed company Biostatistician FSP, Early Phase Location: Durham, reputed company Carolina, reputed company of America Job Level: FSP reputed company Biostatistician (FSP) for Early Phase Location: Home-based in the U.S. or Canada Why DSSS? Data Sciences reputed company Solutions, DSSS or DS3, is a unit reputed company reputed company that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This means you get reputed company the benefits of working for an industry leading global CRO while operating reputed company a sponsor environment and utilizing sponsor systems. These sponsor clients include world class pharmaceutical and biotech companies offering you unique opportunities to influence the reputed company of medicine and advance therapies to market. Job reputed company: The reputed company Biostatistician is responsible for providing statistical support for drug development programs in early phases. Additional Benefits: • Home-based remote working opportunities • Work/life balance as reputed company as flexible schedules • Collaborating with motivated, high-performance, statistical and research teams • Technical training and tailored development curriculum • Research opportunities that match your unique skillset • Promising career trajectory • Job stability: long-term engagements and re-deployment opportunities • reputed company on bringing new therapies to market rather than project budgets and change orders. • Experience with regulatory submissions. • Engaging, fast-paced environment. • Good work-life balance. Job Requirements: • Collaborate with multi-disciplinary project teams to establish project timelines. • reputed company statistical input to study protocols. • Write the statistical sections of clinical trial protocols, while consulting with reputed company experts. • Write statistical analysis plans. • Monitor internal and CRO project activities including timelines, deliverables, and availability of resources. • Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise. • Contribute to clinical study reports and other regulatory documents e.g., DSURs, Briefing Documents, etc. • reputed company guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings, and figures. • Interpret study results and review reports of study results for accuracy. • Participate and contribute to authoring of Clinical Development Plan. • Support exploratory analyses and medical affairs publications. • Participate in reputed company-IND and NDA activities. • Participate in other activities and meetings to support Biostatistics and the Development Team as needed. Qualifications: • PhD in Statistics, Biostatistics, or reputed company field with 5+ years industry experience. • MS in Statistics, Biostatistics, or reputed company field with 7+ years of industry experience. • Early Phase Oncology experience is PREFERRED. • Experience to help with reputed company escalation studies, efficacy endpoints, and solid tumor. • 1+ years with regulatory submissions. • Successful publication experience. • Demonstrate ability to work independently in project management and decision making. • reputed company to effectively communicate his/her reputed company and to manage programmers in a constructive manner. • Ability to use reputed company and/or R to reputed company efficacy analyses and validate important data derivations reputed company necessary. • Understanding of ICH GCP as reputed company as general knowledge of industry practices and standards. • Experience with CDISC, including SDTM, Adam, CDASH. Desired Experience: • Familiarity with R programming language and other statistical software, including EAST. • Experience with Bayesian reputed company. • Knowledge of simulations, multivariate analyses, and biomarker analyses. #LI-Remote #LI-NITINMAHAJAN reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. reputed company is proud to be an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, status as a protected veteran, or any other status protected by applicable law. #J-18808-Ljbffr Salary: USD 72000 - 108000 per year Experience: 5 years required Apply tot his job Apply To this Job