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
The Sr. Manager, Statistical Programming is responsible for leading Statistical Programming efforts for clinical trials at REGENXBIO. The responsibilities include primary and/or validation programming for assigned clinical trials. Additionally, the responsibilities of the Associate Director can include the assigning and tracking of work for more junior programmers.
What You'll Be Doing
- Provides leadership/expertise in day-to-day statistical programming in support of ongoing projects
- Develops and/or validates SAS programs to generate SDTM/ADaM datasets following industry standards, regulatory requirements, and statistical instructions
- Develops and/or validates 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
- Documents data and programming information in accordance with SOPs, guidelines and industry standards
- Manages timelines for statistical programming activities
- Assists the Head of Statistical Programming in developing templates for derived dataset specifications, programming specifications, and other supporting documents
- Develops SAS macros, templates and utilities for reporting and data cleaning
- Oversees and manages Contract Research Organizations (CROs)
- Develops and tests 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:
- Minimum of Bachelor’s Degree
- Bachelor’s Degree in Computer Science, Statistics, Mathematics, or a scientific discipline preferred
- SAS programming at an expert level
- Minimum 10 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
- SAS programming at an expert level
Why Should You Apply?
By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients.We offer a comprehensive and competitive benefit plan which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more!In addition, professional development is important to us. By joining our team, you’ll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally. Apply for this job
