Principal Statistician CMC Quantitative Sciences
Principal Statistician CMC Quantitative Sciences
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1 Vacancy
Job Description
The Role:
Moderna is seeking a strategic handson Principal Scientist to join the CMC Quantitative Sciences (QS) team in Norwood MA. As a key member of the team you will lead statistical strategy and for analytical method lifecycle activities and applied modeling for analytical instrumentation across clinical latestage and commercial programs.
You will serve as the primary statistical thought partner to Analytical Development and Quality guiding phaseappropriate strategies for method development validation transfer and monitoring. In addition to traditional statistical techniques you will apply quantitative and machine learning methods to analytical technologies and contribute to the implementation of nextgeneration QC tools including automation and highthroughput analytics. You will also support regulatory submissions and help shape Modernas statistical approach to data monitoring and method comparability.
Beyond your technical contributions you will mentor others and help build a culture of statistical excellence across CMC. This is an ideal role for someone who thrives in applied problemsolving enjoys coaching and wants to make a tangible impact in a highpaced sciencefirst environment.
The ideal candidate is selfdriven an excellent communicator and aligned with Modernas core values of being Bold Collaborative Curious and Relentless. Your leadership will help ensure our statistical approaches remain innovative scalable and essential to the success of our growing therapeutic platform.
Heres What Youll Do:
Lead statistical support for analytical method lifecycle activities including method development validation transfer and investigations across clinical latestage and commercial programs
Serve as a subject matter expert on statistical aspects of the analytical method lifecycle guiding experimental design data analysis and decisionmaking
Contribute to regulatory filings by authoring and reviewing statistical content for reference standards method validation and method transfer in regulatory submissions
Drive analytical monitoring innovation by developing automated QC data monitoring systems and integrating industry best practices in analytical method lifecycle activities
Support nextgeneration analytics by enabling automated QC highthroughput Raman and advanced integration of complex chromatographic methods
Guide postapproval changes including reference standard updates and analytical method optimizations
Partner crossfunctionally with scientists engineers and quality teams to ensure experiments are welldesigned and statistical methods are appropriately applied
Educate and influence partners by building statistical literacy and promoting the use of sound statistical reasoning in analytical decisionmaking
Communicate clearly to both technical and nontechnical audiences translating complex analyses into actionable insights
Champion statistical best practices to promote consistency rigor and scalability across CMC QS and the broader Moderna platform
Stay current and contribute to the field through literature review training and conference engagement
Heres What Youll Bring to the Table:
Minimum Qualifications
PhD in Statistics 5 yrs) MS 8 10 yrs) or BS 10 15 yrs) in Statistics or a related field
Strong foundation in applied statistical methods such as DOE regression capability analysis control charts and multivariate analysis
Experience with analytical method validation and lifecycle activities in a regulated environment
Proficiency in JMP R or SAS
Effective communicator who can translate statistical thinking into actionable strategies for nonstatistical audiences
Understanding of regulatory guidance (ICH Q2/Q14 USP . WHO)
Preferred Qualifications
Familiarity with eCTD submissions and response to HA questions
Experience with analytical QC automation highthroughput methods or largescale monitoring systems
Knowledge of phaseappropriate GMP principles and riskbased decision making
Proven mentoring or people management experience
Competencies
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
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)
#LIKP1Required Experience:
Staff IC
Employment Type
Full-Time
