Sr. Director, Statistical Programming

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. The Sr. Director of Statistical Programming will be involved in the analysis and reporting broad range of clinical data including clinical efficacy, safety, and biomarkers etc. across Modernas infectious disease programs that are leveraging cutting-edge mRNA science to create transformative medicines for patients

Heres What Youll Do:

• Leader in statistical programming to develop compelling vision to effectively motivate the team, design the organization structure to empower effective communications, and devise the workflow to ensure continuous improvement and high productivity

• Develop statistical programming strategies on quantitative data analyses, leveraging data to accelerate the clinical development and regulatory submissions across portfolio with a focus on infectious diseases TA

• Serve as the statistical programming leader and point-of-contact in multiple clinical development teams responsible for determining statistical programming methods and delivering results with high quality and on time

• Serve as the Subject Matter Expert (SME) for effective interactions with global regulatory agencies regarding statistical programming requirements on data analyses and data traceability and addressing regulatory questions

• Leader in bringing innovative statistical programming methods to help enhance the efficiency and effectiveness of clinical studies data readouts to inform critical decision makings

• Oversee CROs statistical programming deliverables for infectious disease TA studies to ensure high-quality and meet the pre-specified timelines

• Take the lead role to develop the Statistical Programming outsourcing strategy including setting up internal infrastructure to enable FSP working model

• Conduct oversight on CRO deliverables, and to focus on process improvement and operational excellence

• Develop quality control processes for SAS programing and execute for regulatory reporting, publications, and press releases

• Review and/or author SOPs and/or Work Instructions related to statistical programming practices

• Oversee statistical programming related study and systems audits by both internal and external, and effectively address audit questions and findings

Heres What Youll Bring to the Table:

• MS or PhD (or equivalent degree) with 15+ years of relevant work experience in Biotech, Pharma, Clinical Research Organizations, or other relevant organizations

• 8+ years of experience managing statistical programming group with 10+ members

• 5+ years of managerial experience working with / oversee CRO activities

• Working knowledge of relevant FDA, EU, ICH guidelines and regulations.

• Outstanding communication skills (verbal and written).

• Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.

• Mastery of SAS language and procedures commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH

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
  Discretionary year-end shutdown
  Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 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!

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.

About Moderna

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 persons 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.

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