Senior Manager - Statistical Programming
Company: Novo Nordisk
Posted on: May 28, 2023
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?
We are looking to hire a Senior Manager, Statistical Programming. 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.
This position will report to the Executive Director of Biostatistics and Programming.
Provide oversight of statistical programming activities of CRO across multiple studies
Collaborate closely with Biostatistics, Clinical Data Management, Clinical Operations, and other functions to provide programming support
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
Review CDISC specifications for SDTM and ADaM datasets as well as define.xml, reviewers guide documents and Pinnacle 21 validation reports
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
Participate in the development and review of Statistical Programming SOPs
Mentor junior statistical programmers
0-10% overnight travel required.
Master's degree in Biostatistics, Computer Science or a related field plus five to seven 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 8 to 10 years of relevant industry experience
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.
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.
About the Department
Keywords: Novo Nordisk, Lexington , Senior Manager - Statistical Programming, Executive , Lexington, Kentucky
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