Associate/Director CMC Statistician at Moderna Therapeutics in Norwood, Massachusetts

Job Description:

The Role:
The CMC Statistician is a key member of the Technical Development organization responsible for supporting the integration of statistical strategy throughout CMC. In this role you will contribute directly to advancing Moderna s portfolio of products from development to commercial manufacturing, and help build technical platforms for a rapidly expanding pipeline. You will collaborate as a key project resource and team member with scientists and engineers working on the forefront of mRNA science. You will design experiments and develop predictive models for technical processes and analytical methods.

Here's What You ll Do:
Working with teams of engineers and scientists, you will advise on statistical approaches, collaborate on design of experiments, and perform and teach others to conduct data analysis. Responsibilities will include:
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Actively participate in project team meetings to understand the context for application of statistical methods
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Independently develop strategies for experiment design and model building
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Perform data modeling or teach others as needed
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Organize the analyses into clear presentations and written reports
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Stay current on developments in statistics and data science.
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Manage your own multiple projects, negotiate expectations on timing, and deliver on commitments
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Review and provide feedback on the work of colleagues; contribute your technical expertise to the team and be open to learning/cross-training in other technical areas; lead and develop other team members as needed

Here s What You ll Bring to the Table:
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10+ years experience applying statistical methods in process development, manufacturing, and analytical sciences
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MS degree or higher in Statistics or related discipline with BS degree in engineering or science
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Experience with commonly used methods including Design of Experiments (DOE), variance component analysis, multivariate analysis, linear and nonlinear modeling
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Working knowledge of the quality concepts used in the GMP production and development of biotech products such as PPQ, method validation, CPPs/CQAs, IQ/OQ/PQ, raw material testing and qualification, reference standards, comparability, and risk assessments
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Advanced skills using one or more statistical programs or languages (JMP or R, for example)
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Outstanding communication skills (verbal and written).
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Ability to manage multiple projects in a fast-paced environment.
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Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
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Excellent writing skills and proficiency with Word and Excel; comfort with other standard programs in the Microsoft Office suite of products
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Ability to teach basic-to-intermediate methods to scientists without formal training in statistics
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Comfortable working remotely and in virtual, on-line environments such as meeting rooms (audio/video), file shares, and collaboration spaces

Here s What We ll Bring to the Table:
- On-site subsidized cafeteria or catered lunches
- Company-provided iPhone
- Free parking, monthly subway pass or a subsidized commuter rail pass
- Free annual corporate membership to Bluebikes
- Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
- Flexible Spending Accounts for medical expenses and dependent care expenses
- 16 weeks of 100% paid parental leave for all new parents
- 16 weeks 100% paid family caregiver leave
- 20 weeks 100% paid medical leave
- Eligible for Moderna Month ? (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
- Adoption assistance and discounts to local childcare centers, as well as access to care.com
- 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
- A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- 15 days vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

About Moderna:
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The Company s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been ranked in the top ten of Science s list of top biopharma industry employers for the past five years. To learn more, visit .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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