Associate Director, Biostatistics

5 months ago

Cambridge, United States Moderna, Inc. Full time

The Role:

This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Associate Director of Biostatistics will be involved in the design, execution, analysis, and reporting clinical studies across Modernas development programs that are leveraging cutting-edge mRNA science to create transformative medicines for patients

Heres What Youll Do:

  • Leader in bringing innovative statistical thinking and methods to help drive applications of suit-for-purpose statistical methods that enhance the probability of successes for clinical development programs

  • Collaborate with internal and external stakeholders to ensure effective quantitative approaches are applied to the collection and analysis of a wide variety of data types

  • Develop statistical sections of clinical development plans, protocols, statistical analysis plans, and key specifications for statistical programming implementation of analyses

  • Plan, manage, and track biostatistics activities, timelines, and resources and assure operational excellence

  • Frequently interact with regulatory agencies and effectively address the statistical questions and requests

  • Review and/or author SOPs and/or Work Instructions related to biostatistics practices

  • Collaborate with and manage internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals

  • Provide technical guidance and mentoring to junior team members.

    Heres What Youll Bring to the Table:

  • PhD in statistics (or equivalent degree) with 6+ years or master with 9+ years of relevant working experience in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations.

Excellent statistical knowledge with the ability of applying the knowledge to solve scientific and clinical problems.

Working knowledge of relevant ICH guidelines, US, EU and other regions regulations.

Experience working on oncology, vaccine/infectious disease and rare disease clinical studies and regulatory interactions are preferred.

Experience working with CROs, vendors, and relationship management preferred.

Experience working with clinical safety, or working as independent unblinded statistician is preferred.

Outstanding communication skills (verbal and written).

Ability to manage multiple projects in a fast-paced environment.

Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.

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)

-

  • Associate Director, Biostatistics

    5 days ago

    cambridge, United States Proclinical Staffing Full time

    Associate Director of Biostatistics - Permanent - Remote within USProclinical Staffing are partnered with a truly exciting Mid-Sized Global Pharma in their search for an Associate Director, Biostatistics. Primary Responsibilities:The business specialize across a diverse set of Rare Diseases with their work culminating in 9 products successfully approved and...

  • Associate Director, Biostatistics

    1 week ago

    cambridge, United States Proclinical Staffing Full time

    Associate Director of Biostatistics - Permanent - Remote within USProclinical Staffing are partnered with a truly exciting Mid-Sized Global Pharma in their search for an Associate Director, Biostatistics. Primary Responsibilities:The business specialize across a diverse set of Rare Diseases with their work culminating in 9 products successfully approved and...

  • Associate Director, Biostatistics

    1 week ago

    Cambridge, United States Proclinical Staffing Full time

    Associate Director of Biostatistics - Permanent - Remote within USProclinical Staffing are partnered with a truly exciting Mid-Sized Global Pharma in their search for an Associate Director, Biostatistics. Primary Responsibilities:The business specialize across a diverse set of Rare Diseases with their work culminating in 9 products successfully approved and...

  • Associate Director, Biostatistics

    1 week ago

    Cambridge, United States Proclinical Staffing Full time

    Associate Director of Biostatistics - Permanent - Remote within USProclinical Staffing are partnered with a truly exciting Mid-Sized Global Pharma in their search for an Associate Director, Biostatistics. Primary Responsibilities:The business specialize across a diverse set of Rare Diseases with their work culminating in 9 products successfully approved and...

  • Associate Director, Biostatistics

    4 weeks ago

    Cambridge, Massachusetts, United States Bicycle Therapeutics Limited Full time

    Job DescriptionThe Associate Director of Biostatistics will be a key member of the Biometrics function with accountability for biostatistical activities in Bicycle clinical studies.Key ResponsibilitiesProvide key biostatistical input and quantitative deep thinking to support a wide variety of projects in clinical development.Closely collaborate with partner...

  • Associate Director, Biostatistics and Data Science

    4 weeks ago

    Cambridge, Massachusetts, United States Bicycle Therapeutics Full time

    Job SummaryBicycle Therapeutics is seeking a highly skilled Associate Director of Biostatistics to join our Biometrics team. This key role will be responsible for providing biostatistical expertise to support the development of our novel class of medicines, referred to as Bicycle molecules.The ideal candidate will have a strong background in biostatistics,...

  • Director Biostatistics

    6 months ago

    Cambridge, United States Intellia Therapeutics Full time

    Why Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...

  • Associate Director

    4 weeks ago

    Cambridge, Massachusetts, United States FogPharma Full time

    About the RoleFogPharma is seeking a highly skilled Associate Director to join our Clinical Development team. As a key member of our team, you will be responsible for developing and executing clinical trials for our innovative therapeutics.Key Responsibilities:Design, plan, and implement protocols for assigned investigational productsSupport related...

  • Associate Director, Global Real-World Evidence and Health Outcomes Research

    1 month ago

    Cambridge, Massachusetts, United States GlaxoSmithKline Full time

    Job SummaryGlaxoSmithKline is seeking a highly skilled professional to lead our Real-World Evidence and Health Outcomes team. As Associate Director, you will be responsible for designing and implementing quantitative evidence syntheses to support our medicines and vaccines. You will work closely with cross-functional teams to develop and execute data...

  • Associate Director

    4 weeks ago

    Cambridge, Massachusetts, United States FogPharma Full time

    Clinical Development Opportunities at FogPharmaFogPharma is a leading biotechnology company revolutionizing medical treatments by precisely drugging intracellular targets. We are seeking a highly skilled Associate Director to join our Clinical Development team.In this role, you will contribute to the development of new drug modalities for cancer and other...

  • Associate Director

    4 weeks ago

    Cambridge, Massachusetts, United States FogPharma Full time

    About the RoleFogPharma is a pioneering biopharmaceutical company that is revolutionizing the medical possibilities for patients by precisely drugging intracellular targets. We are seeking an experienced Associate Director to join our Clinical Development team and contribute to the development of a new drug modality for cancer and other diseases with unmet...

  • Senior Director of Clinical Research

    4 weeks ago

    Cambridge, Massachusetts, United States Pfizer Full time

    Job SummaryThe Senior Director of Clinical Research will lead the development of first-in-man, proof-of-mechanism, and proof-of-concept studies for novel biological and small molecule therapies in respiratory disease programs.Key ResponsibilitiesDevelop disease-specific global networks of investigators and key opinion leaders for trial design, management,...

  • Associate Director, Oncology Genomics

    4 months ago

    Cambridge, United States GlaxoSmithKline LLC Full time

    They will be involved in the processing and analysis of NGS data (with a focus on WES/WGS, SNVs/CNVs, ctDNA) and will need a solid understanding of computational approaches for cancer genome analysis and cancer biology to derive meaningful and reproducible biological insights.Experience in complex molecular data integration, such as transcriptomics,...

  • Associate Director Data Operations

    2 months ago

    Cambridge, United States eTeam Full time

    Title: Associate Director Data OperationsLocation: Cambridge - MADuration: 12 Months’Pay Rate: $76/hrPOSITION SUMMARYWe are looking for a self-directed professional to support Digital Health Technology [DHT] (wearable sensors) and imaging components set-up and monitoring within clinical trials; specifically focused on the operational initiation/set-up,...

  • Associate Director, Pharmacometrics Lead

    6 days ago

    Cambridge, United States Takeda Full time

    About the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as...

  • Associate Director, Pharmacometrics Lead

    3 days ago

    cambridge, United States Takeda Full time

    About the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as...

  • Associate Director, Pharmacometrics Lead

    6 days ago

    cambridge, United States Takeda Full time

    About the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as...

  • (Sr.) Director, Clinical Operations

    1 day ago

    Cambridge, United States Proclinical Staffing Full time

    (Sr.) Director, Clinical Operations - Permanent - Cambridge, RemoteProclinical is working alongside a biotech company seeking a (Sr.) Director, Clinical Operations to lead and manage clinical trials within early-stage programs. This role focuses on overseeing studies from startup to completion, ensuring operational excellence, and contributing to study...

  • (Sr.) Director, Clinical Operations

    1 day ago

    Cambridge, United States Proclinical Staffing Full time

    (Sr.) Director, Clinical Operations - Permanent - Cambridge, RemoteProclinical is working alongside a biotech company seeking a (Sr.) Director, Clinical Operations to lead and manage clinical trials within early-stage programs. This role focuses on overseeing studies from startup to completion, ensuring operational excellence, and contributing to study...

  • Associate Director

    4 weeks ago

    Cambridge, Massachusetts, United States Harvard University Full time

    Job Summary:The Associate Director will report to the Director of CAMLab and will serve as chief administrator of CAMLab projects/programs and their creative direction. The position will be responsible for the day-to-day management of CAMLab project/program development, leadership, and organization. Working closely with the CAMLab Director, the person in...