Job DescriptionThe Associate Director position will be responsible for providing statistical programming leadership for a wide range of clinical studies in oncology and neuroscience, accountable for all programming related activities throughout drug development from study design to regulatory filings and publications.Essential Functions:1. Maintain processes, code and documentation to enable routine transfer of datasets to and from M&S and other necessary associated programming activities2. Manage study schedule dates of deliverables and priorities in consultation with global head of M&S3. Maintain project schedule in consultation with global head of M&S4. Liaise with global head of M&S on outsourcing of the creation of NONMEM datasets5. Review M&S specs ensuring they follow the latest standard or if applicable follow a previous study within that compound and liaise with the M&S person responsible for the project on any changes required for the specifications.6. Assure planning and timely completion of draft and postlock final SDTM/ADaM datasets by NBG/OBG Biostats7. Review M&S specifications for the purpose of setting up the work order if outsourced8. Work with NBG (Neurology) and OBG (Oncology) Heads of Programming to assign Lead Programmer if in-house and ensure QC resource is available9. Liaise with NBG and OBG with regards to creation of define files for submissions10. If work is outsourced:Kick off meeting to introduce the CRO to the M&S analystTransfer of data and all relevant docsWeekly meetings with the CRO to answer any questions and liaise with the Head of M&S when the M&S analyst doesnt know the answerTransfer of all programs and data sets back to Eisai and ensure they run on the Eisai server11. Maintain standard NONMEM datasets specifications12. Create datasets for conducting population PK and PK/PD analysesJob QualificationsRequirements:BSc or Masters Degree in relevant field and 8+ years of statistical programming experience in clinical development or equivalentSubmission expertiseAdvance knowledge of Regulatory & Compliance Requirements for Biostatistics processesSolid leadership skills, including management of people resources, FTEs, Contractors, and/or CRO vendors within a matrixed environment.Experience in assigned TA is required.Experience in clinical development statistical programming methods and processes in industry setting required.
Associated topics: biostatistics, data analyst, probability, statistics, c
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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