Alkermes, Inc.
Associate Director, Statistical Programming
Alkermes, Inc., Waltham, Massachusetts, United States, 02254
The Associate Director of Statistical Programming, as a member of the Biostatistics & Statistical Programming Department, will contribute to Alkermes to achieve the goals of continuing growth in neuroscience. The Associate Director will combine technical and project management skills to lead programmers to
develop and validate SAS programs to produce high quality deliverables for in-house and outsourced projects in CDISC compliance to meet regulatory requirements.
In addition, this individual willsupport the automation and innovation within programming group to drive effective and efficient statistical programming. This is a hybrid, on-site position based in Waltham, MA. Primary Responsibilities Function as lead programmer to coordinate all activities related to study or project level statistical programming activities. Design and develop programming specifications and SAS programs for producing and validating CDISC compliant datasets to support the generation of outputs for regulatory submission. Produce and validate regulatory submission tables, figures and listings, support ad-hoc exploratory analysis in a timely fashion and of high quality Design, develop, implement and maintain innovative statistical programming automation reporting tools to effectively support multiple projects. Provide project management and technical guidance to ensure operational and technical excellence. Mentor junior level staff in programming practices, implementation of standards and project management. Represent statistical programming in cross-functional teams. Work in close collaboration with other functions including biostatistics, clinical operations, data management and regulatory operations to define deliverables, develop timelines and ensure alignment of expectations Work with IT to develop and maintain programming environment to ensure data security and efficient analysis and reporting Basic Requirements Advanced degree strongly preferred (M.S. or Ph. D) with strong analytical skills Minimum 8+ years experiences in pharmaceutical/biotech and/or CRO setting Preferred Requirements Proven expert in SAS programming and analytical skills using BASE SAS, SAS/STAT, SAS/GRAPH and SAS MACROS etc. Extensive CDISC SDTM and ADaM knowledge with significant experience writing ADaM specifications using robust and detailed instructions. Strong hands-on SAS programing skills for clinical trial reporting. Experience with electronic FDA submission. Prefer proficiency in other data analysis programming languages, such as R and Python. Ability to learn new programming language quickly and be motivated to utilize them in the clinical development field. Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials Strong interpersonal, organizational, and multi-tasking skills Excellent attention to detail and problem-solving skills Good project management skills, CRO oversight skills, professional attitude, self-improvement mentality with positive attitude Good written and oral presentation skills and ability to communicate effectively Ability to think creatively and independently, and to form sound opinions and make sensible decisions in a dynamic environment Neuroscience experience is a plus SAS LSAF experience is a plus
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develop and validate SAS programs to produce high quality deliverables for in-house and outsourced projects in CDISC compliance to meet regulatory requirements.
In addition, this individual willsupport the automation and innovation within programming group to drive effective and efficient statistical programming. This is a hybrid, on-site position based in Waltham, MA. Primary Responsibilities Function as lead programmer to coordinate all activities related to study or project level statistical programming activities. Design and develop programming specifications and SAS programs for producing and validating CDISC compliant datasets to support the generation of outputs for regulatory submission. Produce and validate regulatory submission tables, figures and listings, support ad-hoc exploratory analysis in a timely fashion and of high quality Design, develop, implement and maintain innovative statistical programming automation reporting tools to effectively support multiple projects. Provide project management and technical guidance to ensure operational and technical excellence. Mentor junior level staff in programming practices, implementation of standards and project management. Represent statistical programming in cross-functional teams. Work in close collaboration with other functions including biostatistics, clinical operations, data management and regulatory operations to define deliverables, develop timelines and ensure alignment of expectations Work with IT to develop and maintain programming environment to ensure data security and efficient analysis and reporting Basic Requirements Advanced degree strongly preferred (M.S. or Ph. D) with strong analytical skills Minimum 8+ years experiences in pharmaceutical/biotech and/or CRO setting Preferred Requirements Proven expert in SAS programming and analytical skills using BASE SAS, SAS/STAT, SAS/GRAPH and SAS MACROS etc. Extensive CDISC SDTM and ADaM knowledge with significant experience writing ADaM specifications using robust and detailed instructions. Strong hands-on SAS programing skills for clinical trial reporting. Experience with electronic FDA submission. Prefer proficiency in other data analysis programming languages, such as R and Python. Ability to learn new programming language quickly and be motivated to utilize them in the clinical development field. Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials Strong interpersonal, organizational, and multi-tasking skills Excellent attention to detail and problem-solving skills Good project management skills, CRO oversight skills, professional attitude, self-improvement mentality with positive attitude Good written and oral presentation skills and ability to communicate effectively Ability to think creatively and independently, and to form sound opinions and make sensible decisions in a dynamic environment Neuroscience experience is a plus SAS LSAF experience is a plus
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