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    Manager, Statistical Programming - Cambridge, United States - BioSpace, Inc.

    BioSpace, Inc.
    BioSpace, Inc. Cambridge, United States

    3 weeks ago

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    Description
    Job Details

    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 Manager of Statistical Programming will be responsible for statistical programming deliverables across Modernas development programs that are leveraging cutting-edge mRNA science to create transformative medicines for patients

    Heres What Youll Do:
    • Primarily responsible for quality and timely delivery of SDTM artifacts (SDTM Specifications, datasets, , SDRG, Annotated CRF)
    • Develop SAS macro program for SDTM mapping for electronic submissions of data in CDlSC format to ensure meets regulatorys compliance
    • Expertise in SAS macro for raw data checking
    • Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros
    • Participate in the review of CRFs, CRF Completion Guide, Edit checks specification, data validation plans
    • Design SDTM annotation CRF and SDTM specification as per the CDISC SDTM IG and ensure they meet downstream ADaM and Reporting requirements
    • Maintain high quality of deliverables with validation and resolution of issues surfaced in Pinnacle21
    • Collaborate closely with Study leads, Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Moderna to effectively address their needs for programming support.
    • Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc) to ensure meeting project timelines and goals
    Heres What Youll Bring to the Table:
    • MS or PhD (or equivalent degree) with 3+ years or BS with 5+ years of relevant work experience in Biotech, Pharma, Clinical Research Organizations, or other relevant organizations
    • Mastery of SAS language and procedures commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
    • Strong understanding of EDC, SDTM metadata and metadata driven
    • Demonstrates advanced knowledge of electronic submissions and CDlSC
    • Experience working with CROs, vendors, and relationship management 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 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:
      Vacation, sick time and holidays
      Volunteer time to participate within your community
      Discretionary year-end shutdown
      Paid sabbatical after 5 years; every 3 years thereafter
    • Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
    • 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, 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 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 . (EEO/AAP Employer)

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