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 Senior Manager / Associate Director of Statistical Programming will be providing leadership and hands-on support to multiple clinical study teams on all statistical programming activities across Moderna’s development programs that are leveraging cutting-edge mRNA science to create transformative medicines for patients
Here’s What You’ll Do:
Lead one or more projects for all programming deliverables and milestones from study start-up to regulatory submission. Oversee CRO programming activities for multiple clinical studies, maintaining programming infrastructure and ensuring compliance with SOPs to produce high quality and timely deliverables
Serve as the Lead Programmer and the point-of-contact for projects’ entire statistical programming efforts. This may include but not limited to:
Independently develop and validate technical programming specifications and programs, generate analysis datasets based on SDTM and ADaM standards, and produce SAP specific tables, listings, and figures/graphs.
Ensure effective filing of all statistical programming related study documentation following Moderna’s SOPs
Develop and execute programming quality control processes supporting regulatory reporting, publications, and press releases
Work closely with the Statistical Programming Director in all aspects of the management and development of the Statistical Programming team. Responsibilities include:
Participate in the development and review of all the SOPs for the Statistical Programming group to ensure processes are implemented with 100% compliance.
Create and/or review programming plans and ensure proper resource allocation and prioritization.
Act as the primary department contact, when needed, to ensure all department activities are carried out with high quality
Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Moderna to effectively address their needs for programming support.
Oversee statistical programming contractors and mentor junior team members
Here’s What You’ll Bring to the Table:
BS/BA/MA/MS 8+ or PhD 5+ years statistical programming experience in biotech / pharmaceutical companies or CROs.
4+ years programming project management experience in biotech / pharmaceutical companies or CROs.
Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment with a demonstrated mastery of SAS/STAT procedures.
Extensive experience and proven skills in use of SAS within a Statistical Programming environment and complete knowledge and understanding of the statistical programming processes, procedures, and roles.
Working knowledge of CDISC SDTM and ADaM standards to support Biostatistics in statistical analysis, including generating analysis data listing, tables, and figures and create all files necessary to support electronic submissions in the eCTD format.
Strong verbal and written communication skills and proven ability to clearly and effectively present technical information.
Excellent understanding of the roles and responsibilities of all related disciplines, in particular Biostatistics, Clinical Data Management, and Pharmacovigilance.
Advanced experience with:
Constructing technical programming specifications.
Good Clinical Practices.
Good Programming Practices.
21CFR Part 11 Standards.
Integrated Summary Safety/Efficacy Analyses.
Safety data and Coding Dictionaries (MedDRA and WHODD).
Creating programming files required to support an electronic submission in the eCTD format.
Here’s What We’ll Bring to the Table:
On-site subsidized cafeteria or catered lunches
Free parking, monthly subway pass or a subsidized commuter rail pass
Free annual corporate membership to Bluebikes
Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
Flexible Spending Accounts for medical expenses and dependent care expenses
16 weeks of 100% paid parental leave for all new parents
16 weeks 100% paid family caregiver leave
20 weeks 100% paid medical leave
Eligible for “Moderna Month” (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
Adoption assistance and discounts to local childcare centers, as well as access to care.com
401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
Voluntary legal assistance plan
15 days’ vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The Company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been ranked in the top ten of Science’s list of top biopharma industry employers for the past five years. To learn more, visit www.modernatx.com.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.