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Director, CMC Quantitative Sciences
2 months ago
The Role
In this role, you will provide strategic statistical guidance and direction to the entire CMC Statistics team, playing a key role in shaping the future of our development and production capabilities. You will oversee a team of statisticians, provide mentorship, and set priorities for the team while ensuring the alignment of statistical strategies with the company's objectives.
The ideal candidate will be self-motivated with exceptional communication skills, committed to the Moderna core values of being Bold, Collaborative, Curious, and Relentless. Your strategic input and leadership 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. Join us and contribute to the development of groundbreaking vaccines and therapies that improve human health.
Heres What Youll Do
Strategic Leadership:
Develop and implement advanced statistical methodologies to support the company's strategic goals.
Provide high-level statistical consultation and direction to senior management and cross-functional teams, influencing key business decisions.
Drive the design and execution of complex experimental designs and statistical models to address multifaceted research questions.
Team Leadership:
Lead and manage the CMC Statistics team, overseeing the work of junior and senior statisticians.
Foster a culture of statistical excellence and continuous learning within the team.
Provide mentorship and professional development opportunities for team members.
Build a high performing team, including delivering feedback, evaluating team member performance, & evaluating potential candidates.
Project Oversight:
Oversee multiple high-impact projects, ensuring timely and effective delivery of statistical analyses and reports.
Collaborate with cross-functional leaders to align statistical strategies with overall project and company objectives.
Serve as the senior statistical expert on critical projects, guiding the application of sophisticated statistical techniques to our most complex and challenging problems.
Apply technical expertise to individual analysis methodology, guiding decisions that balance technical detail, simplicity, and business needs
Cross-Functional Collaboration:
Partner with leaders in Process Development, Analytical Development, Quality, Manufacturing, and Nonclinical Research to integrate statistical principles into all phases of product development and production.
Champion data-driven decision-making processes, ensuring robust statistical frameworks are embedded in project plans and research initiatives.
Innovation and Continuous Improvement:
Stay abreast of the latest advancements in statistical science, biostatistics, and regulatory guidelines to ensure the team remains at the cutting edge of the field.
Identify and implement new statistical tools and software to enhance the efficiency and effectiveness of the CMC Statistics team and the CMC Quantitative Sciences team on the whole.
Lead initiatives to streamline statistical processes, reducing development timelines and improving the quality of our biotechnological innovations.
Regulatory and Compliance:
Ensure compliance with regulatory requirements and industry standards for statistical practices, providing expert guidance during regulatory submissions and audits.
Represent the company in interactions with regulatory agencies, effectively communicating statistical methodologies and findings, including in CTD sections, responses to questions, and meetings with agencies
Additional duties as may be assigned from time to time
Heres What Youll Need (Basic Qualifications)
PhD in Statistics or related discipline with 10+ years of relevant experience; MS degree in Statistics or related discipline with 10 - 15 years of relevant experience; or BS degree in Statistics or related discipline with 15+ years of relevant experience
Minimum of 5 years in direct team leadership role
Heres What Youll Bring to the Table (Preferred Qualifications)
Demonstrated leadership experience, including managing and mentoring a team of statisticians, with the ability to inspire and develop a high-performing team
Proven track record of leading and delivering complex statistical projects in a fast-paced, dynamic environment
Strong collaborative skills, with a demonstrated ability to work effectively with cross-functional teams and senior management
Exceptional communication skills, capable of conveying complex statistical concepts to non-statistical audiences
Demonstrated ability to innovate and drive continuous improvement in statistical practices and methodologies
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
Thorough comprehension of regulatory guidance, including ICH, WHO, USP guidelines
Experience in regulatory interactions and submissions, including eCTD submissions, response to health authority questions, and agency meetings
Skilled in teaching non-statisticians basic & intermediate statistical methods
Advanced skills using one or more statistical packages or languages (e.g., JMP, SAS, or R)
Proficiency with Microsoft Office suite (i.e. Word, Excel, PowerPoint) 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 optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:Vacation, sick time and holidays
Volunteer time to participate within your community
Discretionary year-end shutdown
Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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 peopleare 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 in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office 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.com/careers to 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. Were 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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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