Manager, Statistical Programming

Moderna • Bethesda, MD

2d • $109,200 - $174,600 • Hybrid

About The Position

The Role Moderna Services, Inc. seeks a Manager, Statistical Programming for its Bethesda, Maryland location. Here's What You’ll Do Provide statistical programming deliverables across mRNA infectious disease therapeutics development programs. Support oversight of Clinical Research Organizations (CRO) all 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. Participate in the review of Case Report Forms (CRFs) and CRF Completion Guides, Statistical Analysis Plans (SAP) and Shells, and Study Data Tabulation Model (SDTM) Annotation CRF, SDTM, and Analysis Data Model (ADaM) specifications. Independently develop Quality Control (QC) Programs to support internal QC. Develop programs to support ad-hoc requests-based analysis. 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. Participate in the development of CRF, edit check specifications, and data validation plans. Collaborate with internal and external functions, including CRO, software vendors, and clinical development partners, among others, to ensure meeting project timelines and goals.

Requirements

• Requires a Master’s degree, or foreign equivalent, in Statistics or a closely related field and 3 years of experience as a Statistical Programmer or related position performing statistical programming for clinical research trials.
• 3 Years of experience must include: Utilizing SAS language, procedures and functions including SAS BASE, SAS SQL, SAS Macros, SAS STATS, & SAS GRAPHS to conduct statistical programming for clinical study reporting; Applying FDA, EMA, & ICH guidance to review study documents (CRFs & SAPs) and prepare submission-ready CDISC deliverables including SDTM and ADaM datasets; and Resolving Pinnacle 21 Enterprise findings to achieve submission-acceptable conformance and audit readiness.
• Must also have experience with pharmaceutical research including sponsor-side experience collaborating with CROs to oversee project deliverables, data quality, and timelines across projects.

Responsibilities

• Provide statistical programming deliverables across mRNA infectious disease therapeutics development programs.
• Support oversight of Clinical Research Organizations (CRO) all 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.
• Participate in the review of Case Report Forms (CRFs) and CRF Completion Guides, Statistical Analysis Plans (SAP) and Shells, and Study Data Tabulation Model (SDTM) Annotation CRF, SDTM, and Analysis Data Model (ADaM) specifications.
• Independently develop Quality Control (QC) Programs to support internal QC.
• Develop programs to support ad-hoc requests-based analysis.
• 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.
• Participate in the development of CRF, edit check specifications, and data validation plans.
• Collaborate with internal and external functions, including CRO, software vendors, and clinical development partners, among others, to ensure meeting project timelines and goals.

Benefits

• Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities to help you plan for the future
• Location-specific perks and extras
• The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager