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Senior Manager/Associate Director, Biostatistics

Location: Rockville
Posted on: June 7, 2021

Job 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 Senior Manager/Associate Director of Biostatistics, you will provide statistical expertise and leadership for clinical development programs at REGENXBIO, including response to statistical issues arising from regulatory, research and early development, and other settings. It will be critical to build strong collaboration with clinical development and study teams in order to identify and meet their needs for statistical support. Additionally, you will be responsible for study design, data analysis and interpretation of results, and will also provide statistical strategy and contribute to clinical development plans and regulatory responses, and other documents. You will also collaborate with other Biometrics functions at REGENXBIO and in contract research organization (CRO), as needed.

What you'll be doing

  • Lead statistical activities for clinical development programs and/or gene therapy studies
  • Provide statistical expertise in the assigned projects and development programs
  • Guide the project teams in using the most efficient or innovative study design by considering the regulatory agencies' requirements for the country and regions the compound will be submitted, and help to maximize the success of the drug product
  • Serve as a project statistician and ensure the study designs are scientifically sound and the efficacy and safety information meets regulatory requirements
  • Participate in protocol development and prepare statistical sections in the protocol, Statistical Analysis Plan (SAP), and Clinical Data Presentation Plan (CDPP)
  • Ensure consistency in data collections, derived data definitions, analysis file structure, statistical analyses and result interpretations throughout the drug development
  • Lead or participate in the planning and analysis of efficacy and safety data and ensure that efficacy and safety summaries meet regulatory requirements
  • Provide input to the entire clinical development plan to ensure that the overall strategy can deliver the pre-specified target product profile (TPP) and that proposed studies have appropriate clinical trial designs
  • Research statistical methodologies for rare disease and address specific statistical issues in the design of clinical studies for Phase 1 through Phase 4
  • Guide CRO biostatistician or statistical programmers, if necessary, on assigned projects to ensure consistency in derived data definitions, analysis files structure, analysis methodologies, and accuracy of analysis results
  • Ensure timely delivery of high quality deliverables
  • Author documents and responses submitted to health authorities globally
  • 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:

  • MS or PhD in statistics, biostatistics, or other related field with high statistical content; PhD preferred.
  • Minimum of 7 years, if PhD, of experience working in the pharmaceutical industry (10 years if MS).
  • Knowledge of ICH/EMEMA/FDA guidelines.
  • Ability to innovate creatively in a clinical study design setting.
  • Ability to communicate with clarity.
  • Ability to effectively collaborate and influence other functions.
  • Experience working with Statistical Programming and Data Management functions
  • Demonstrated ability to serve effectively as a team leader
  • Experience in regulatory interactions and submissions
  • Comprehensive knowledge of statistical methods and applications in study design and analysis
  • Programming skills in SAS (required) and R (preferred)
  • Experience in implementation of CDISC, SDTM, and ADaM datasets
  • Knowledge of statistical software package such as nQuery, EAST, etc.

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.

Keywords: REGENXBIO, Rockville , Senior Manager/Associate Director, Biostatistics, Other , Rockville, Maryland

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