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Job Title: Statistician II
Duration: 12 months
Location: Framingham, MA
Bachelor's Degree in Statistics or related scientific field (Master's Degree preferred). Member of Mechanical Circulatory Support (MCS) statistical team responsible for Statistical analysis using SAS and other tools across multiple trials.
Primary tasks include data analysis, programming of tables and listings within targeted timelines for interim and/or final report submission; support on-going needs for ad-hoc analysis.
ESSENTIAL FUNCTIONS: Works with Biostatistics, Data Management and Clinical Operations to conduct statistical programming for MCS. Contributes to clinical data reports for all IDE updates and submissions and interfaces with other departments within MCS (Marketing, Healthcare economics, Clinical Engineering, etc.) for special programming needs. In addition, the candidate will provide assistance in preparing manuscripts for publication and data summaries for professional meetings and for Board presentations.
DEPARTMENT SPECIFIC/NONESSENTIAL FUNCTIONS:
Other duties as assigned with or without accommodation
Expertise in statistical software, preferably SAS to support regulatory studies. High efficiency in SAS programming and/or other statistical analysis tools
Knowledge of Regulatory Requirements; Knowledge of relevant statistical regulatory guidance and standards (e.g., FDA, ICH and EMEA)
Excellent organizational skills and attention to detail o Prioritize and effectively manage several projects simultaneously o Meet project deliverables and timelines from a statistical perspective; Work collaboratively within a multidisciplinary team
Oral and Written Communication Skills: Competency in English both in oral and in written; Succinctly write statistical analysis documents, (e.g., analysis plans): Competency in explaining the results of the statistical analysis to the clinical study team and other clients in verbal and writing o Ensuring that the results have been appropriately interpreted in the report
MINIMUM REQUIREMENTS: Education and Experience:
Bachelor's Degree in Statistics or related scientific field (Master's Degree preferred).
Relevant experience with data collection/statistics preferably for medical device and/or pharmaceutical clinical trials. Skills/Qualifications Other Skills:
Competency in SAS programming and Statistical analysis methods/tools
Computer literacy in MS Word, Excel, PowerPoint, Access etc.
Oracle Clinical system knowledge a plus
Ability to prioritize and multitask
Able to effectively communicate with Clinical, Data Management and Statisticians
Excellent organizational skills and attention to detail.
Ability to speak, write and understand English to comply with written procedures, instructions, SOPs and other documents
Ability to work as a team and autonomy will be appreciated Competencies:
Ethics and Values
WORKING CONDITIONS: Normal office conditions. Minimal travel may be required (? 5%). 0-5 years' experience
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