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.
Principal Responsibilities
· 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
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
...Join to apply for the VP Compliance Counsel role at Bayview Asset Management, LLC 14 hours ago Be among the first 25 applicants... ...Management is an investment management firm focused on investments in mortgage and consumer credit, including whole loans, asset-backed...
...documents, to ensure compliance with worldwide safety regulations and corporate policies.... ...and ad-hoc queries with Pharmacovigilance Physician Request deletions as necessary... ...without Bachelors degree but with knowledge of Drug Safety usually exhibited by minimum 5 years...
Health Information Management Specialist, (Remote) 2 days ago Be among the first 25 applicantsLensa is the... ...completing two-year college level coursework in an RHIT program.Minimum... ...veteranSeniority level Seniority level Entry levelEmployment type Employment type...
...We are currently working with a well-established general contractor that is looking to add a Construction Project Manager to their team in the Orange County and Los Angeles area. This individual will play a key role in managing and delivering life science and commercial...
...performance and also a quarterly bonus based on hotel service scores Career growth - Mentorship, cross-training, development plans, management training, and more-over 200 internal promotions this year Health and well-being - Medical, dental, vision, prescription, life...