- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collection and mapping data definitions thereby ensuring alignment with industry ( CDISC ) standards for Health Authority regulations. Working knowledge of various ... Non-EDC), and direct experience implementing industry standards (eg, Controlled Terminologies, CDISC CDASH, SDTM, ADaM, etc.) for data submissions and relative… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data concepts, working knowledge of data collections (EDC & Non-EDC), industry standards ( CDISC / SDTM), and technical skills for integrating and importing ... cleaning needs for DS Programs / Studies.- Serve as the subject matter expert for Study Data Managers during the planning/start-up, conduct and close-out of external… more
- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The RoleThe Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication ... of contact related to Statistics for designated compound/indicationFollow scientific and technical progress within the field of biostatistics in drug development and… more
- BeiGene (San Mateo, CA)
- …Proven experience leading teams in support of global and regional filings. + Expert -level knowledge and extensive hands-on experience of CDISC standards such as ... on operational excellence, resource optimization, standardization, automation, innovation, and CDISC standards implementation. + Oversee the work of internal and… more
- Harvard University (Cambridge, MA)
- …partners and vendors + Strong written and verbal communication skills; technical writing experience is desirable The following cultural competencies are also ... ongoing review and development of quality systems and processes, including CDISC implementation and other internal/external initiatives. The Associate Director will… more
- Pfizer (Groton, CT)
- …+ Comply with applicable SOPs and work practices + Serve as subject matter expert in one or more technologies + Lead and contribute to cross-functional technical ... an emphasis on building data collection and assimilation solutions + Technical skills and experience using relational databases. Medidata Rave experience required.… more
- Lilly (IN)
- …development, edit checks programming, and Quality Testing. + Serve as a subject matter expert in the use of EDC platforms and their suite of products including ... data standard decisions and strategies for a study and/or program + Provide oversight, technical support, and guidance to the study teams in the efficient use of the… more
- IQVIA (Durham, NC)
- …validation checks. + Write statistical sections of integrated reports. + Provide expert statistical input into and review of statistical deliverables (ie analysis ... and Abilities:** + Excellent written and oral communication skills including grammatical/ technical writing skills + Excellent attention and accuracy with details +… more
- IQVIA (Durham, NC)
- …for an industry leading global CRO while collaborating directly with expert cross-functional sponsor teams. Sponsor clients include world class pharmaceutical and ... Collaborating with motivated, high-performance, statistical and research teams + Technical training and tailored development curriculum + Research opportunities that… more
- Bristol Myers Squibb (Princeton, NJ)
- …and guidance while maintaining emphasis on exceptional analysis quality. Act as expert consultant for escalated issues for TA level analysis standards. **External ... the end to end analysis deliverables. Collaborates to identify innovative technical advances, elevating the value of analysis standards. Evaluates analysis standards… more
- DRT Strategies, Inc. (Silver Spring, MD)
- Overview DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, the US Navy, state and local ... needed Required Experience + Minimum of 3 years professional experience. + Technical proficiency in programming languages- R (mandatory). + R programming - ability… more
