Manager, Statistical Programming

The Role

Moderna Services Inc. seeks a Manager Statistical Programming for its Bethesda Maryland location.

Heres What Youll 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.

Heres What Youll Bring to the Table (Basic Qualifications)

• Requires a Masters 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.

• May telecommute 30% of the time.

The salary range for this role is $109200 to $174600. This range reflects the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. The minimum target pay for this particular position based on its primary location is $149400 to $174600. An individuals placement within the range will depend on several factors including but not limited to specific competencies relevant education qualifications certifications experience skills performance and business or organizational needs.

For summary of benefits and to apply visit (Job ID: R19060) or email resume and cover letter to with subject line: R19060

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Pay & Benefits

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

• 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.