Director - Statistical Programming

About the Department

The Lexington Site is home to a growing Development organization, part of Novo Nordisk following its acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. The Lexington Development team is responsible for leading the clinical advancement of Dicerna's research pipeline of GalXC™ and GalXC-Plus™ RNAi investigational therapies and select candidates from the broader Novo Nordisk portfolio, targeting both rare and prevalent diseases. The Lexington Development team's rich heritage of collaboration, calculated risk-taking and agility complemented by the scale and resources of the global Development organization, define a unique clinical development team that maintains its agility to efficiently advance clinical candidates through development. Located in one of the most vibrant biotechnology innovation hubs in the world, and part of the growing biotech ecosystem in Lexington, Massachusetts, the Lexington Site will offer you the opportunity to collaborate with extraordinary talent and to continuously develop, while working toward our collective mission to improve patient lives. Together, we are driving change. Are you ready to make a difference?

The Position

We are looking to hire a Director, Statistical Programming. This individual will be responsible for the oversight of statistical programming activities for all clinical development programs. This individual will proactively oversee the quality and timely delivery of all statistical programming deliverables. This individual will be responsible for all in-house programming activities, including individual studies, Integrated summary of Safety and efficacy, responding regulatory agency questions and any periodic updates, etc. This individual will proactively interact with internal cross function teams and external vendors, and make the programming decisions to meet business need.

Relationships

This position will report to the Executive Director of Biostatistics and Programming.

Essential Functions

• Provide oversight of statistical programming activities and provide technical guidance
• Collaborate closely with Biostatistics, Clinical Data Management, Clinical Operations, and other functions to provide programming support and represent statistical programming as strategic partner
• Oversee the activities of CRO programming team to ensure adherence to scope of work and service agreements, and to ensure deliverables are met in accordance with study milestones/timelines and with quality
• Perform programming QC/validation of SAS code for SDTM datasets, ADaM datasets and TFLs and hands-on programming in house
• Review CDISC specifications for SDTM and ADaM datasets as well as define.xml, reviewers guide documents and Pinnacle 21 validation reports
• Provide programming strategy for timely response to regulatory agency questions from FDA, EMA, PMDA, and NMPA
• Program TFLs for study related ad hoc analyses, posters, and presentations
• Participate in internal study team meetings as well as teleconferences with vendors and study personnel
• Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans (SAP), Mock Tables, Figures and Listings (TFL) shells
• Review and ensure adherence to programming budgets
• Participate in the creation of company data and programming standards
• Manage Contracting statistical programmers to ensure good quality and timely delivery
• Mentor junior statistical programmers

Physical Requirements

0-10% overnight travel required.

Qualifications

• Master's degree in Biostatistics, Computer Science or a related field plus 10 years of statistical programming experience in the pharmaceutical / CRO industry; or Bachelor's degree in in Biostatistics, Computer Science or a related field with at least 12 years of relevant industry experience
• Great leadership and decision-making skills
• Strong knowledge with CDISC standards for SDTM and ADaM and statistical programming requirements for regulatory submissions
• Excellent SAS programming skills, including SAS/Base, SAS/STAT, SAS/GRAPH, SAS/SQL and SAS/Macro
• Experience with NDA/BLA or other regulatory filing, including ISS or ISE
• Global clinical trial and CRO management experience
• Strong working knowledge of FDA/EMA & ICH/GCP regulations and guidelines
• Excellent written and verbal communication skills
• Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast-paced, team-based environment

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.