Manager, Statistical Programming - Cambridge, United States - Moderna
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.
Here's What You'll Do:
Primarily responsible for quality and timely delivery of SDTM artifacts (SDTM Specifications, datasets, , SDRG, Annotated CRF)
Develop SAS macro program for SDTM mapping for electronic submissions of data in CDlSC format to ensure meets regulatory's compliance
Expertise in SAS macro for raw data checking
Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros
Participate in the review of CRFs, CRF Completion Guide, Edit checks specification, data validation plans
Design SDTM annotation CRF and SDTM specification as per the CDISC SDTM IG and ensure they meet downstream ADaM and Reporting requirements
Maintain high quality of deliverables with validation and resolution of issues surfaced in Pinnacle21
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.
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
Strong understanding of EDC, SDTM metadata and metadata driven
Demonstrates advanced knowledge of electronic submissions and CDlSC
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
- D iscretionary yearend shutdown
- Paid sabbatical after 5 years; every 3 years thereafter
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.
Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
Moderna is a smoke-free, alcohol-free and drug-free workMore jobs from Moderna
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