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
The annual base salary for this position ranges from $184,071 to $198,796. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
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