- Vacation, sick time and holidays
- Volunteer time to participate within your community
- D iscretionary year-end shutdown
- Paid sabbatical after 5 years; every 3 years thereafter
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Sr. Statistician, CMC Quantitative Sciences - Norwood, United States - Moderna
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Description
Sr. Statistician, CMC Quantitative Sciences page is loadedSr. Statistician, CMC Quantitative Sciences
Apply
locations
Norwood, Massachusetts
Technical Development
time type
Full time
posted on
Posted 4 Days Ago
job requisition id
R15859
The Role
In this role, you will provide strategic statistical guidance and leadership to project teams.
Working collaboratively with cross-functional teams, you will partner with colleagues in Process Development, Analytical Development, Quality, Manufacturing, and Nonclinical Research.
Your understanding of these domains will be essential in identifying the most effective statistical approaches to address complex research questions and drive the scientific decision-making process.
Your role will focus on the application of statistical methods and will also involve fostering a culture of statistical excellence within the organization.
By teaching statistical principles and championing data-driven strategies, you will contribute to the development of a robust statistical framework that enhances our research and production capabilities.
The ideal candidate will be self-motivated with outstanding communication skills, embodying the Moderna core values of being Bold, Collaborative, Curious, and Relentless.
Your strategic input 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.
Here's What You'll DoServe as strategic partner to product teams, providing project-specific support on justification of specifications, shelf-life 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 data-driven 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 non-statistician partners, stakeholders, and 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
Partner with process development teams to enhance our platform by applying Quality by Design principles to process characterization and process change activities
Adhere to best statistical practices to drive consistency across CMC statistics and Moderna's platform.
Act as key advisor to scientist partners
Additional duties as may be assigned from time to time
Here's What You'll Need (Minimum Qualifications)
PhD in Statistics or related discipline with - 5 years of relevant experience; MS degree in Statistics or related discipline with - 8 years of relevant experience; or BS degree in Statistics or related discipline with years of relevant experience
Deep understanding 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 non-statisticians in basic & intermediate statistical methods
Outstanding communication skills, both verbal and written
Proficiency with Microsoft Office suite (i.e. Word, Excel, PowerPoint)
Here's What You'll 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 risk-based decision making
Skilled at balancing practical importance, business impact, and scientific rigor associated with decisions
Strong collaborative skills in a cross-functional matrix organizational structure
Capable of managing multiple projects in a dynamic environment
Detail-oriented with a passion for science and data analysis
Self-motivated 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 high-growth, transformational company that is
Bold, Relentless, Curious, and Collaborative.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
Family care benefits, including subsidized back-up care options and on-demand tutoring
Free premium access to fitness, nutrition, and mindfulness classes
Exclusive preferred pricing on Peloton fitness equipment
Adoption and family-planning benefits
Dedicated care coordination support for our LGBTQ+ community
Generous paid time off, including:
401k match and Financial Planning tools
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Complimentary concierge service including home services research, travel booking, and entertainment requests
Free parking or subsidized commuter passes
Location-specific 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 world-class 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.
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 visitto learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free 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 proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's 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 E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society.
We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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/AAP Employer)
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Sr. Manager, Regulatory Science, CMC
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At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA).
This novel drug platform builds on the discovery that modified mRNA can direct the body's cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells.
We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.
Our Mission :
To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients.
Our Vision :
To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.
Third Party Staffing AgenciesM oderna does not accept unsolicited resumes from any source other than directly from candidates.
For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position.
Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes.
Reasonable Accommodation NoticeModerna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws.
Please inform the company's personnel representative by calling or emailingif you need assistance completing any forms or to otherwise participate in the application process.
Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.
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