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  • Manager/Sr Manager, Statistical Programming at REGENXBIO Inc. in Rockville, MD

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  • Post Date : May 12, 2024
  • Apply Before : Jun 12, 2024
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Job Detail

  • Offered Salary 0
  • Commitment Full Time
  • Compensation Paid
  • Required education level Bachelor’s degree

Job Description

Description Who we are REGENXBIO is an exceptional place to work. You’ll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters – to patients, to their families, and to their communities. The opportunity As the Manager/Senior Manager, Statistical Programming, you will be responsible for leading Statistical Programming efforts at REGENXBIO which includes primary and/or validation programming for assigned clinical trials. Additionally, your responsibilities can include the assigning and tracking of work for more junior programmers. What you’ll be doing Provide leadership/expertise in day-to-day statistical programming in support of ongoing projects Develop and/or validate SAS programs to generate SDTM/ADaM datasets following industry standards, regulatory requirements, and statistical instructions Develop and/or validate SAS programs to generate statistical output (e.g. TLFs) of clinical trial data as specified in the Statistical Analysis Plan (SAP), as required for regulatory and safety review reasons (i.e. DSUR or IDMC deliverables), and for ad hoc analysis as requested Document data and programming information in accordance with SOPs, guidelines and industry standards Manage timelines for statistical programming activities Assist the Head of Statistical Programming in developing templates for derived dataset specifications, programming specifications, and other supporting documents Develop SAS macros, templates and utilities for reporting and data cleaning Oversee and manage Contract Research Organizations (CROs) Develop and test SAS codes for clinical trial database logic checks Assign tasks to and monitor timelines for junior programmers It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and Qualifications: Bachelor’s Degree required; preferably in Computer Science, Statistics, Mathematics, or a scientific discipline SAS programming at an expert level Minimum 6 (Manager) or 8 (Sr Manager) years of experience in statistical programming in a clinical trial environment Understanding of the drug development process and the functions and roles in a Pharmaceutical/Biotech clinical organization Excellent knowledge of regulatory requirements as related to statistical programming (e.g., CDISC standards, 21 CFR Part 11, FDA requirements, electronic submission standards, etc.) Excellent knowledge of concepts related to statistical programming (e.g., coding dictionaries, annual reporting, EDC systems, etc.) Outstanding verbal and written communication skills Ability to effectively project manage and assign tasks to other programmers Ability to build successful relationships and interact at the project team level. Salary Range: $100K — $150K Minimum Qualification Life Sciences, Software DevelopmentEstimated Salary: $20 to $28 per hour based on qualifications

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