Biostatistics and Programming-Biostatistician Consultant

Biostatistics and Programming-Biostatistician Consultant Biostatistics and Programming-Biostatistician Consultant Direct message the job poster from Aequor Our 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 program Identify opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making Qualifications · 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 environment Education · MS/Ph.D. in Statistic, Biostatistics, Mathematics or related field Seniority level Seniority level Mid-Senior level Employment type Employment type Contract Job function Job function Science Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Aequor by 2x Get notified about new Biostatistician jobs in New Haven, CT . Revenue & Coding Analyst - Radiology - (Medical coding experience needed) *AVAILABLE TO WORK REMOTE* Planetree Person-Centered Care Consultant, Europe Derby, CT $90,000.00-$110,000.00 9 months ago Remote Professional Coding Educator/Auditor Remote Professional Coding Educator/Auditor Planetree Person-Centered Care Consultant, USA Derby, CT $90,000.00-$110,000.00 5 months ago Business Development Manager (USA East Coast, AI) Connecticut, United States $260,000.00-$300,000.00 1 hour ago Connecticut, United States $300,000.00-$360,000.00 1 hour ago Associate Faculty - Business Intelligence and Analytics (online) Director of Business Development - Digital Health Call Center Specialist - Remote - Part-Time (22.5hrs/wk) - Bilingual REQUIRED (Spanish/English) - $2 General Dentists, Endodontists, & Oral Surgeons – Supporting Military Health Readiness Sr. Clinical Research Director, Core Surgical Innovations Director of Business Development - Forsyth Health - Remote We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr