Manager, Statistical Programming at ModernaTX, Inc. in Princeton, New Jersey

Job Description:

The Role:



Moderna Services, Inc. seeks a Manager, Statistical Programming for its Cambridge, Massachusetts location.



Here's What You'll Do:

• On behalf of a global biotechnology company, provide statistical programming deliverables to support clinical trials across development programs leveraging mRNA science.
  
  


• Support study lead programmer to oversee Contract Research Organization (CRO) programming deliverables and milestones from study start-up to study completion, maintaining programming standards and ensuring compliance with Standard Operating Procedures (SOPs) to produce high quality and timely deliverables.
  
  


• Work closely with study lead programmer on all aspects of the development of the Statistical Programming deliverables.
  
  


• Participate in the review of Case Report Forms (CRFs) and CRF Completion Guide.
  
  


• Participate in the review of SAP and Shells. Participate in the review of Study Data Tabulation Model (SDTM) annotations of CRF, and SDTM and Analysis Data Model (ADaM) specifications.
  
  


• Develop Quality Control (QC) Programs independently to support internal QC for key elements.
  
  


• Develop programs to support ad-hoc requests-based analysis.
  
  


• Collaborate closely with Study leads, Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions to effectively address their needs for programming support.
  
  


• Participate in the development of CRFs, edit check specifications, and data validation plans.
  
  


• Collaborate with internal and external functions to meet project timelines and goals and mentor junior team members.
  
  

Here's What You'll Bring to the Table:




Minimum requirements:

• Requires a Master's degree, or foreign equivalent, in Statistics, Public Health, Epidemiology, or related field and three (3) years of experience in the position offered, or as a Statistical Programmer, Statistical SAS Clinical Programmer, or related position. Alternatively, employer will accept a Bachelor's degree in the specified fields and five (5) years of progressive, post-baccalaureate experience in the specified occupations.
  
  


• Must have at least 3 years of experience with:
  
  
  
  
  • Leveraging clinical knowledge to review protocols and CRFs, and translate the endpoints collected for indication under research;
    
    
  
  
  • Reviewing statistical analysis plans, table shells, SDTM annotation CRF, SDTM and ADaM specifications;
    
    
  
  
  • SAS programming skills, including Macros, SQL, BASE SAS, SAS/STAT and SAS/GRAPH;
    
    
  
  
  • Conducting clinical programming to support clinical data management, data cleaning, data review, and external data reconciliation in accordance with standard operating procedures, study-specific guidelines, and global standards including CDISC, MedDRA, WHO-DD, FDA, and EMEA.
    
    
  
  
  
  

May telecommute 100% from anywhere in the U.S.


Apply at https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx (Job ID: R17079) or email resume and cover letter to careers@modernatx.com with subject line: R17079.



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, the infrastructure 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 people are 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. We're 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 Apply Now