drjobs Principal Statistician CMC Quantitative Science

Principal Statistician CMC Quantitative Science

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1 Vacancy
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Job Location drjobs

Norwood, OH - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

The Role

Moderna is seeking an accomplished Principal Statistician to join our Chemistry Manufacturing and Controls (CMC) Quantitative Sciences team onsite in Norwood MA. As a pivotal member of the CMC Statistics team you will provide strategic statistical guidance and leadership to project teams.

Working collaboratively with crossfunctional teams you will partner with colleagues in Process Development Analytical Development Quality Manufacturing and Nonclinical Research. Your deep understanding of these domains will be essential in identifying the most effective statistical approaches to address complex research questions and drive the scientific decisionmaking process. Your role will not only focus on the application of statistical methods but will also involve mentoring and fostering a culture of statistical excellence within the organization. By teaching statistical principles and championing datadriven strategies you will contribute to the development of a robust statistical framework that enhances our research and production capabilities.

The ideal candidate will be selfmotivated with exceptional communication skills embodying the Moderna core values of being Bold Collaborative Curious and Relentless. Your strategic input and mentorship will be critical in maintaining our position at the forefront of therapeutic innovation as we expand our pipeline and build technical platforms to meet the rapid pace of biotechnological advancement.

Heres What Youll Do

  • Serve as strategic partner to product teams providing projectspecific support on justification of specifications shelflife analysis comparability assessments and investigational analysis

  • Provide consultation to internal stakeholders appropriately addressing research questions by designing proper experiments & matching correct statistical tools to requests

  • Collaborate with scientists engineers and other statisticians to facilitate datadriven decision making fostering a common understanding of statistical principles and interpretation of analysis conclusions

  • Clearly articulate complex analysis methodology & findings to a diverse audience including nonstatistician partners stakeholders and senior management

  • Embed statistical thinking throughout the organization by educating scientists on statistical tools and their application

  • Contribute to regulatory filings by authoring & reviewing statistical content in module 3 of IND IMPD BLA and MAA dossiers

  • Act as subject matter expert for statistical aspects of the analytical method lifecycle including method development qualification validation and investigations

  • Strongly partner with process development teams to enhance our platform by applying Quality by Design principles to process characterization and process change activities

  • Set maintain and model best statistical practices to drive consistency across CMC statistics and Modernas platform.

  • Mentor junior team members & act as key advisor to scientist partners

  • Continue to advance & share your knowledge of relevant CMC topics through literature training & conference attendance

  • Additional duties as may be assigned from time to time

Heres What Youll Need (Minimum Qualifications)

  • PhD in Statistics or related discipline with 5 8 years of relevant experience; MS degree in Statistics or related discipline with 8 10 years of relevant experience; or BS degree in Statistics or related discipline with 10 15 years of relevant experience

  • Mastery of statistical methods such as Design of Experiments (DOE) regression modeling variance component analysis multivariate analysis process capability and control charts

  • Biopharmaceutical development and manufacturing experience with a strong preference for CMC statistics background

  • Advanced skills using one or more statistical packages or languages (e.g. JMP SAS or R)

  • Ability to instruct nonstatisticians in basic & intermediate statistical methods

  • Exceptional communication skills both verbal and written

  • Proficiency with Microsoft Office suite (i.e. Word Excel PowerPoint)

Heres What Youll Bring to the Table (Preferred Qualifications)

  • Familiarity with GMP quality concepts used in pharmaceutical production and development

  • Regulatory writing experience including eCTD submissions and response to health authority questions

  • Thorough comprehension of regulatory guidance including ICH WHO USP guidelines

  • Experience with phase appropriate GMP principles

  • Understanding of risk analysis and riskbased decision making

  • Skilled at balancing practical importance business impact and scientific rigor associated with decisions

  • Strong collaborative skills in a crossfunctional matrix organizational structure

  • Capable of managing multiple projects in a dynamic environment

  • Detailoriented with a passion for science and data analysis

  • Selfmotivated with outstanding communication skills

  • Keen to learn & adapt with the ability to pivot in the face of new data

  • A desire to make an impact as part of a highgrowth transformational company that is Bold Relentless Curious and Collaborative.

At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global wellbeing resources are designed to support youat work at home and everywhere in between.

  • Bestinclass healthcare coverage plus a suite of voluntary benefit programs to support your unique needs
  • A holistic approach to wellbeing with access to fitness mindfulness and mental health support
  • Lifestyle Spending Accounts to personalize your wellbeing journey
  • Family planning and adoption benefits
  • Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary yearend shutdown
  • Savings and investment opportunities
  • Locationspecific perks and extras

About Moderna

Since our founding in 2010 we have aspired to build the leading mRNA technology platform the infrastructure to reimagine how medicines are created and delivered and a worldclass team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission values and mindsets every day our people are the driving force behind our scientific progress and our culture. Together we are creating a culture of belonging and building an organization that cares deeply for our patients our employees the environment and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer a Fast Company Best Workplace for Innovators and a Great Place to Work in the U.S.

As we build our company we have always believed an inperson culture is critical to our success. Moderna champions the significant benefits of inoffice collaboration by embracing a 70/30 work model. This 70 inoffice structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.

If you want to make a difference and join a team that is changing the future of medicine we invite you to visit modernatx/careers to learn more about our current opportunities.

Moderna is a smokefree alcoholfree and drugfree work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!

Moderna is committed to equal employment opportunity and nondiscrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry or citizenship ethnicity disability military or protected veteran status genetic information sexual orientation marital or familial status or any other personal characteristic protected under applicable law.

Moderna is an EVerify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at . (EEO Employer)

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Employment Type

Full-Time

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