Manager, Statistical Programming
Moderna Therapeutics

Job Order #: 21070544

Cambridge, MA 02141

Full Time

40 hours per week

POSTED 7/5/2024

EXPIRES 9/28/2024

Job Description

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 Moderna's development programs that are leveraging cutting-edge mRNA science to create transformative medicines for patients

Here's What You'll Do:

* Support study lead programmer to oversee CRO all programming deliverables and milestones from study start-up to study completion, maintaining programming standards and ensuring compliance with SOPs to produce high quality and timely deliverables

* Serve as a study programming team member and work closely with study lead programmer in all aspects of the development of the Statistical Programming deliverables

* Participate in the review of CRFs and CRF Completion Guide

* Participate in the review of SAP and Shells

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

* Develop QC Programs independently to support internal QC for key elements

* Develop programs to support ad-hoc requests-based analysis with no or minimal supervisor

* 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 CRFs, edit check specifications, and data validation plans

* 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

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

* MS or PhD (or equivalent degree) with 3+ years or BS with 5+ 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

* 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 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
To view the full job description please use the link below.

How To Apply


320 Bent St.
Cambridge, MA 02141

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Moderna Therapeutics


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320 Bent St.
Cambridge, MA 02141