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 Associate Director of Statistical Programming will be responsible for statistical programming deliverables including 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 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 point-of-contact for projects’ entire statistical programming efforts. This may include but not limited to:
Oversee the development and validation of technical programming specifications and programs, and generation of SDTM and ADaM datasets, as well as production of 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 Senior 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 4+ 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.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
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.#LI-MS1