Job ID: 244115148
Job date: 2017-01-10
End Date:
Company : Arrayo (formerly known as Steepconsult Inc) Country : Role : Technician
Job date: 2017-01-10
End Date:
Company : Arrayo (formerly known as Steepconsult Inc) Country : Role : Technician
Job Description:
We are looking to hire several Clinical Biostatisticians with SAS Programming skills to our New York Clinical Practice. This role will support the Biostatistics team by carrying out and conducting programming activities of statistical programmers, and coordinating with external vendors (as required), and to ensure timely and accurate programming and validation activities for clinical studies. You will contribute to the overall efficiency and best practice running of the Biostatistics group, demonstrating the ability to work efficiently and to a high standard within a clinical team environment. Main duties/responsibilities: -Providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following areas: analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), DSUR, PSUR, IB, progress reports, electronic submissions and other internal and external requests (e.g., publications). -Accessing and converting data to SAS from Database management system and PC file formats (e.g., MS Excel, text files). -Working with external vendors in order to develop or monitor the content and structure of SAS data sets. SDTM and ADaM technical knowledge are preferred. In addition, knowledge of agency requirements including ICH, FDA, and other guidances are beneficial. -Knowledge of current FDA submission process (Define.xml, etc.) is strongly recommended. -Developing and maintaining SOPs, SWPs and other related technical documents, providing input to the Database and CRF Development. -Providing input in developing statistical analysis plans, producing specifications of analysis datasets, validation plans, and other related documents. Good understanding with different phases of clinical trials, protocols, and CRF designs. -Maintaining standards for programming activities (SDTM, ADaM, directory structure, etc.), and guiding/coaching Statistical programmers. -Working independently as well as in teams to accomplish tasks and goals defined by supervisor. Attending required training and meetings and bringing in new ideas to improve the programming process. Skills: -Minimum 2 years’ experience in SAS programming for phase I-IV clinical trials in a pharmaceutical. 3+ years’ experience preferred. -Some project experience in a pharmaceutical/CRO programming environment or demonstrated significant leadership of SAS programming activities in a clinical pharmaceutical/CRO environment. -Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office. Knowledge of SDTM and ADaM standards. -Proven experience with UNIX and Windows operating systems. -Understanding of the software development life cycle. -Understanding of FDA guidelines. -Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality. -Applies good judgment and demonstrates initiative to resolve issues. -Strong verbal, written and interpersonal communication skills needed to work effectively in a team environment, managing that team as required. -Great chance to combine your love of science with your software and programming skills. Education: BS/BA, MS, Ph.d in Statistics, Bioinformatics, Mathematices, Life Sciences, Biology, Chemistry, Neuroscience, Medical School, Life Sciences Additional skills: -Hematology, Oncology, Neuroscience, Alzheimer Disease, Epilepsy, Clinical exposure and experience a plus. -CRO Outsourcing, Clinical Services, Vendor Sourcing -Data Management experience all a plus -Biostatiscian Programming a plus SAS-Base Graduate School Clinical experience Graduate School SAS Programming Programs Locations in New Jersey Suburbs.
Additional Info:
Send resumes to pmurphy@teamarrayo.com www.teamarrayo.com https://teamarrayo.com/job-post/sas-clinical-senior-biostatistics-lead/#.WFmfxIWcEh0 Arrayo is known for being a great place to work and build a career. We provide advisory services for organizations in today’s most important industries. Our growth is driven by delivering real results for our clients. It’s also enabled by our culture, which encourages individual development, embraces an inclusive environment, rewards innovative excellence and supports our communities. With qualities like those, it’s no wonder we’re consistently ranked among the best companies to work for by Fortune Magazine, Consulting Magazine, Working Mother Magazine, Diversity Inc. and others. If you’re as passionate about your future as we are, join our team.[Click Here to Access the Original Job Post]
We are looking to hire several Clinical Biostatisticians with SAS Programming skills to our New York Clinical Practice. This role will support the Biostatistics team by carrying out and conducting programming activities of statistical programmers, and coordinating with external vendors (as required), and to ensure timely and accurate programming and validation activities for clinical studies. You will contribute to the overall efficiency and best practice running of the Biostatistics group, demonstrating the ability to work efficiently and to a high standard within a clinical team environment. Main duties/responsibilities: -Providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following areas: analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), DSUR, PSUR, IB, progress reports, electronic submissions and other internal and external requests (e.g., publications). -Accessing and converting data to SAS from Database management system and PC file formats (e.g., MS Excel, text files). -Working with external vendors in order to develop or monitor the content and structure of SAS data sets. SDTM and ADaM technical knowledge are preferred. In addition, knowledge of agency requirements including ICH, FDA, and other guidances are beneficial. -Knowledge of current FDA submission process (Define.xml, etc.) is strongly recommended. -Developing and maintaining SOPs, SWPs and other related technical documents, providing input to the Database and CRF Development. -Providing input in developing statistical analysis plans, producing specifications of analysis datasets, validation plans, and other related documents. Good understanding with different phases of clinical trials, protocols, and CRF designs. -Maintaining standards for programming activities (SDTM, ADaM, directory structure, etc.), and guiding/coaching Statistical programmers. -Working independently as well as in teams to accomplish tasks and goals defined by supervisor. Attending required training and meetings and bringing in new ideas to improve the programming process. Skills: -Minimum 2 years’ experience in SAS programming for phase I-IV clinical trials in a pharmaceutical. 3+ years’ experience preferred. -Some project experience in a pharmaceutical/CRO programming environment or demonstrated significant leadership of SAS programming activities in a clinical pharmaceutical/CRO environment. -Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office. Knowledge of SDTM and ADaM standards. -Proven experience with UNIX and Windows operating systems. -Understanding of the software development life cycle. -Understanding of FDA guidelines. -Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality. -Applies good judgment and demonstrates initiative to resolve issues. -Strong verbal, written and interpersonal communication skills needed to work effectively in a team environment, managing that team as required. -Great chance to combine your love of science with your software and programming skills. Education: BS/BA, MS, Ph.d in Statistics, Bioinformatics, Mathematices, Life Sciences, Biology, Chemistry, Neuroscience, Medical School, Life Sciences Additional skills: -Hematology, Oncology, Neuroscience, Alzheimer Disease, Epilepsy, Clinical exposure and experience a plus. -CRO Outsourcing, Clinical Services, Vendor Sourcing -Data Management experience all a plus -Biostatiscian Programming a plus SAS-Base Graduate School Clinical experience Graduate School SAS Programming Programs Locations in New Jersey Suburbs.
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Additional Info:
Send resumes to pmurphy@teamarrayo.com www.teamarrayo.com https://teamarrayo.com/job-post/sas-clinical-senior-biostatistics-lead/#.WFmfxIWcEh0 Arrayo is known for being a great place to work and build a career. We provide advisory services for organizations in today’s most important industries. Our growth is driven by delivering real results for our clients. It’s also enabled by our culture, which encourages individual development, embraces an inclusive environment, rewards innovative excellence and supports our communities. With qualities like those, it’s no wonder we’re consistently ranked among the best companies to work for by Fortune Magazine, Consulting Magazine, Working Mother Magazine, Diversity Inc. and others. If you’re as passionate about your future as we are, join our team.[Click Here to Access the Original Job Post]