Manager, Statistical Programming

The Role:

Moderna Services, Inc. seeks a/an 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.

• May telecommute up to 2 days per week.

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

Minimum requirements:

• Requires a Master’s degree in Statistics, Applied Statistics or related field and 3 years of experience in the offered position or as a Biostatistician, Analyst/Programmer or related position.  In the alternative, employer will accept a Bachelor’s degree in the specified fields and five (5) years of progressive, post-baccalaureate experience in the specified positions.

• 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 up to 2 days per week.

Apply at https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx (Job ID: 17822) or email resume and cover letter to careers@modernatx.com with subject line: 17822.

#DNI

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• 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 Workplac