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Biostatistics and Programming-Biostatistician ConsultantBiostatistics and Programming-Biostatistician ConsultantDirect message the job poster from AequorOur client a clinical stage biotechnology company is seeking a Biostatistician to join their team for a 1-year contract. As the Biostatistician you will participate in developing plans for clinical developments by using expertise in statistics, design and analysis of clinical trials, and data analytics and mining through cross-functional collaboration and decision-making process. The Biostatistician will provide technical support for ongoing clinical trials, publications, and other business needs.This position can be remote as long as the person can be available to interact with team during reasonable business hours (e.g.9AM to 3PM EST).Will typically work 30-40 hours per week, will vary based on project/workload.Key responsibilities of this role include, but are not limited to:· Provide statistical expertise into clinical development plans, protocol development, statistical analysis plans, regulatory submissions and questions, interpretation of statistical analysis results, and other product support initiatives· Collaborate effectively cross-functionally (e.g., with clinical research, regulatory strategy, data management, statistical programming, medical writing etc.) to facilitate the implementation of statistical analyses, provide statistical input to the CSR and scientific presentations/manuscripts, and serve as internal statistical expert in the overall programIdentify opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-makingQualifications· 10+ years of experience with MS or 7+ year of experience with Ph.D.

in clinical drug development. Prior experience working with oncology studies (solid tumor or hematologic malignancies) is highly preferred. Past NDA/BLA submission experience is desirable.· Proficiency in statistical programming languages/software such as SAS, R, etc.· Extensive knowledge of FDA/ICH guidelines and CDISC standards/implementation guides, 21 CFR Part 11, and familiarity with EMA/CHMP regulations and guidelines; In-depth knowledge of the global drug development process.· Demonstrated written and oral communication skills and ability to work within a team and work independently are required.· Other important requirements include interdependent/analytic thinking skills, building strategic working relationships, and good decision-making capability.· Desire to work in a fast-paced, innovative environmentEducation· MS/Ph.D.

in Statistic, Biostatistics, Mathematics or related fieldSeniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeContractJob functionJob functionScienceIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at Aequor by 2xGet notified about new Biostatistician jobs in New Haven, CTRevenue & Coding Analyst - Radiology - (Medical coding experience needed) AVAILABLE TO WORK REMOTEPlanetree Person-Centered Care Consultant, EuropeDerby, CT $90,000.00-$110,000.00 9 months agoRemote Professional Coding Educator/AuditorRemote Professional Coding Educator/AuditorPlanetree Person-Centered Care Consultant, USADerby, CT $90,000.00-$110,000.00 5 months agoBusiness Development Manager (USA East Coast, AI)Connecticut, United States $260,000.00-$300,000.00 1 hour agoConnecticut, United States $300,000.00-$360,000.00 1 hour agoAssociate Faculty - Business Intelligence and Analytics (online)Director of Business Development - Digital HealthCall Center Specialist - Remote - Part-Time (22.5hrs/wk) - Bilingual REQUIRED (Spanish/English) - $2General Dentists, Endodontists, & Oral Surgeons – Supporting Military Health ReadinessSr. Clinical Research Director, Core Surgical InnovationsDirector of Business Development - Forsyth Health - RemoteWe're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.J-18808-Ljbffr