Manager, Statistical Programming

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. Here’s What You’ll Bring to the Table (Basic Qualifications) 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. May telecommute 30% of the time. The salary range for this role is $109,200 to $174,600. 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 $149,400 to $174,600. An individual’s 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 https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx (Job ID: R19060) or email resume and cover letter to careers@modernatx.com with subject line: R19060 #DNI Pay & Benefits 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 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. Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home