Manager, Statistical Programming

2 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 Senior 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:

Oversee CROs statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines

Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs needs

Serve as a study lead programmer in all aspects of the development of the Statistical Programming deliverables

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

Generate SDTM domains, ADaM datasets, and define.xml files

Participate in the review of SAP and Shells

Participate in the review of SDTM annotation CRF, SDTM and ADaM specifications

Participate in the development of e-CRFs, edit check specifications, and data validation plans

Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices

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

Oversee statistical programming contractors and mentor junior team members

Heres What Youll Bring to the Table:

MS or PhD (or equivalent degree) with 8+ years or BS with 10+ 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

Working knowledge of relevant FDA, EU, ICH guidelines and regulations.

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 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)

-#LI-Remote

  • Manager, Statistical Programming

    2 months ago

    Cambridge, Massachusetts, 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 Senior Manager of Statistical Programming will be responsible for statistical programming deliverables across Modernas development programs that are leveraging cutting-edge...

  • Senior Manager, Statistical Programming

    6 days ago

    Cambridge, United States Kalvista Pharmaceuticals Inc Full time

    Job DescriptionJob DescriptionAbout KalVista Pharmaceuticals, Inc.KalVista Pharmaceuticals, Inc. is a global pharmaceutical company focused on the development and delivery of oral medicines for diseases with significant unmet need, with an initial focus on hereditary angioedema (HAE). The company disclosed positive phase 3 data for the KONFIDENT trial for...

  • Senior Manager, Statistical Programming

    6 days ago

    Cambridge, United States Bicycle Therapeutics Full time

    Job DescriptionJob DescriptionCompany DescriptionBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two...

  • Senior Manager, Statistical Programming

    1 week ago

    cambridge, United States Bicycle Therapeutics Full time

    Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry....

  • Senior Manager, Statistical Programming

    1 week ago

    Cambridge, United States Bicycle Therapeutics Full time

    Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry....

  • Manager, Statistical Programming

    1 month ago

    Cambridge, Massachusetts, 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 Manager of Statistical Programming will be responsible for statistical programming deliverables across Modernas development programs that are leveraging cutting-edge mRNA...

  • Manager, Statistical Programming

    2 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 Manager of Statistical Programming will be responsible for statistical programming deliverables across Modernas development programs that are leveraging cutting-edge mRNA...

  • Sr.Mgr/AD, Statistical Programming

    2 months ago

    Cambridge, United States Kalvista Pharmaceuticals Inc Full time

    Job DescriptionJob DescriptionAbout KalVista Pharmaceuticals, Inc.KalVista Pharmaceuticals, Inc. is a global pharmaceutical company focused on the development and delivery of oral medicines for diseases with significant unmet need, with an initial focus on hereditary angioedema (HAE). The company disclosed positive phase 3 data for the KONFIDENT trial for...

  • Manager, Statistical Data Analytics

    3 weeks ago

    Cambridge, Massachusetts, 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 Manger of of Statistical Data Analytics will be involved in analyses, visualization, and interpretation of broad types of data across Modernas research and development...

  • Manager, Statistical Data Analytics

    2 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 Manger of of Statistical Data Analytics will be involved in analyses, visualization, and interpretation of broad types of data across Modernas research and development...

  • Statistical Methodology Lead

    2 months ago

    Cambridge, Massachusetts, United States UCB Full time

    Make your mark for patientsWe are looking for a Statistical Methodology Lead who is innovative, committed and creative to join us in our Centre of Excellence for Statistical Innovation, based out of our offices in Cambridge, MA, Raleigh, NC or Atlanta, GA. About the roleYou will serve as an influential statistical researcher, consultant and technical leader...

  • Statistical Analyst in Biotechnology

    1 week ago

    Cambridge, Massachusetts, United States Wisen HR Full time

    Job OverviewCompany: Wisen HRLocation: Various locations availablePosition Summary: This role is pivotal in the examination of intricate biological datasets and plays a crucial part in supporting multiple stages of clinical research. The position requires a high level of proficiency in statistical methodologies, data analysis, and effective communication of...

  • Advisor - Statistics (Pre-Clinical Statistician)

    4 weeks ago

    Cambridge, Massachusetts, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Advisor - Statistics (Pre-Clinical Statistician)

    4 weeks ago

    Cambridge, Massachusetts, United States Lilly Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Advisor - Statistics (Pre-Clinical Statistician)

    4 weeks ago

    Cambridge, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Advisor - Statistics (Pre-Clinical Statistician)

    4 weeks ago

    Cambridge, United States Lilly Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Associate Director, Biomarker Statistics

    2 weeks 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 Clinical Biomarkers will serve as a scientific leader and point of contact for clinical teams in the Infectious Disease (ID) space with responsibilities...

  • Sr Statistical SAS Programmer

    2 weeks ago

    Cambridge, United States INTELLECTT INC Full time

    Job Title: Sr. Statistical SAS ProgrammerLocation: Cambridge, MA Onsite / Remote- RemoteClient Industry: PharmaceuticalRequired Skills: CDISC SDTM, ADaM. SAS programmingJob Responsibilities:Key Highlights of what we are looking for:Bachelor's degree is required, Master's degree in Statistics, Mathematics, Computer Science, Computer Information Systems or...

  • Sr Statistical SAS Programmer

    3 weeks ago

    Cambridge, United States Intellectt Inc Full time

    Job Title: Sr. Statistical SAS ProgrammerLocation: Cambridge, MA Onsite / Remote- RemoteClient Industry: PharmaceuticalRequired Skills: CDISC SDTM, ADaM. SAS programmingJob Responsibilities:Key Highlights of what we are looking for:Bachelor’s degree is required, Master’s degree in Statistics, Mathematics, Computer Science, Computer Information...

  • Sr Statistical SAS Programmer

    3 weeks ago

    Cambridge, United States Intellectt Inc Full time

    Job Title: Sr. Statistical SAS ProgrammerLocation: Cambridge, MA Onsite / Remote- RemoteClient Industry: PharmaceuticalRequired Skills: CDISC SDTM, ADaM. SAS programmingJob Responsibilities:Key Highlights of what we are looking for:Bachelor’s degree is required, Master’s degree in Statistics, Mathematics, Computer Science, Computer Information...