Associate Director, Statistical Programming

Job Title: Associate Director, Statistical Programming at Moderna

About Moderna:

Moderna, founded in 2010, has consistently been at the forefront of mRNA technology, working to revolutionize the biotech industry. Our mission focuses on transforming how medicines are developed and delivered, driven by a dedicated team committed to healthcare innovation.

The Role:

We are looking for a highly skilled Associate Director of Statistical Programming to join our dynamic clinical development group. This pivotal position will lead statistical programming activities, ensuring excellence across multiple development programs at Moderna. This exciting opportunity will leverage your expertise in mRNA to develop transformative medicines.

Key Responsibilities:

• Manage and oversee statistical programming deliverables from CROs for various clinical studies to maintain high-quality standards and adhere to timelines.
• Develop, validate, and maintain SAS and/or R programs that meet the tailored needs of clinical development programs.
• Provide technical leadership in SAS programs and applications for effective reporting of clinical trial data and regulatory submissions in CDISC format.
• Create SDTM domains, ADaM datasets, and define.xml files for statistical analysis.
• Develop tables, figures, and listings as per the statistical analysis plans.
• Establish and execute quality control processes for SAS programming, regulatory reporting, publications, and press releases.
• Contribute to the development of CRFs, edit check specifications, and data validation plans.
• Support exploratory analyses in response to internal needs and regulatory agency requests.
• Define and maintain data repository contents associated with statistical programming.
• Review and author SOPs and work instructions aligned with best practices in statistical programming.
• Collaborate effectively with internal and external stakeholders to meet project timelines and objectives.
• Mentor junior team members and oversee contracted statistical programming professionals.

Your Qualifications:

• Advanced degree (MS or PhD) with 10+ years, or BS with 12+ years of relevant experience in Biotechnology, Pharmaceuticals, CROs or related fields.
• Expertise in SAS language, Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH.
• Familiarity with FDA, EU, ICH guidelines, and regulations.
• Exceptional communication skills and proven ability to manage multiple projects in a high-paced environment.
• Experience in CROs and vendor management is preferred.

Why Join Moderna:

At Moderna, we offer an innovative and inclusive suite of benefits which include, but are not limited to, advanced medical, dental, and vision coverage, flexible spending accounts, generous paid leave packages, 401k match, and exclusive company perks and benefits aimed at bolstering the health and well-being of our employees and their families.

We believe that a diverse and inclusive workforce is key to our success and are committed to creating a workplace where every employee is valued and respected. Moderna is proud to be an equal opportunity employer and an affirmative action employer, firmly standing against discrimination on the basis of any personal characteristics.

If you are driven to make a substantial impact in the biotech industry and possess the necessary qualifications, visit our careers page at to apply for the Associate Director, Statistical Programming position.

Moderna is committed to a diverse and inclusive environment and is an E-Verify Employer in the United States. Qualified applicants with criminal histories will be considered in accordance with legal requirements. Accommodations are available for applicants with disabilities throughout the recruitment process.

Join us in our mission to change medicine and change lives!