Senior Manager/Manager, Statistics - Remote

Summary of the Position:

The Statistics Sr/Manager leads the CMC Statistics team, which is one of the primary groups within the CMC Data and Advanced Analytics COE. This position supports the statistical needs of nonclinical groups through managing the CMC Statistics team's day to day work and tactical projects, while ensuring the COE's strategic goals are achieved. This is a remote position.

Responsibilities include but are not limited to

:

  • Manage our team of CMC statisticians, lead and coordinate statistical efforts throughout CMC.
  • Provide sound strategic, scientific, and statistical input to our CMC Statistics team in support of the ongoing and the future work in nonclinical research and development projects, through their work in
  • design of experiments and by using appropriate statistical methodology and sample size.
  • preparation of statistical analysis plans; analysis of experimental and historical data.
  • Creating design of experiments and performing various types of statistical analyses to develop predictive models and optimize conditions for processes, methods, and drug product/drug substance storage.
  • performing stability analysis to identify degradation rates and expiration dates.
  • Preparing the statistical section of technical reports and presentations.
  • Engaging in discussions and research to ensure the central place of applied statistics in research, development, quality, and validation projects.
  • Ensure multiple projects are managed effectively to meet internal customers' deadlines with high quality of standards.
  • Explain statistical designs and concepts to internal customers
  • Responsible for ensuring the administrative tasks for the CMC Statistics team are completed in a timely manner.

Minimum requirements:

  • A degree in Statistics/Biostatistics, Bioengineering, Chemical Engineering, or a related field
  • For the Manager level, BS degree with 9+ years of industry or Master's degree with 6+ years of industry experience or PhD degree with 4+ years of industry
  • For the Sr Manager level, BS degree with 12+ years of industry or Master's degree with 9+ years of industry experience or PhD degree with 7+ years of industry

Previous experience in managing a team of CMC Statisticians

  • Sound knowledge of theoretical and applied statistics is required, preferably with an emphasis on experimental design in biotechnology, statistical process control, analytical method development, process characterization, formulation development, stability, power calculations, etc.
  • The candidate should have hands-on experience with using and scripting statistical software packages including JMP.

Familiarity with ICH guidelines.

    Experience in the drug development field is preferred.

    • Must be an effective and proactive leader, team player, able to thrive in a fast-paced team environment, and also work independently on projects.

    Excellent interpersonal, oral, and written communication skills.

    • Mentorship ability to influence team members and communicate statistical concepts across functions.

    Originally posted on

    Back to blog

    Common Interview Questions And Answers

    1. HOW DO YOU PLAN YOUR DAY?

    This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

    2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

    When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

    3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

    Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

    4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

    With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

    5. HOW DO YOU PROCESS INFORMATION?

    Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

    6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

    Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

    7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

    Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

    8. HOW TO PRIORITIZE WORK?

    The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

    9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

    Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

    10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

    This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...