Senior Statistical Programmer

About the Department                                                                                                                                    

Our Boston Research & Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our greater Boston R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients.

The team is comprised of collaborative, diverse and passionate people who have a true sense of pride in their work and are committed to helping others grow and develop their careers. You’ll also have a platform to engage with key stakeholders on a global scale throughout the entire pipeline process. And while changing the future of diabetes, obesity and MASH treatment is no easy task, we also recognize the importance of an enjoyable workplace, which is why we’ve cultivated a culture of fun, ingenuity and innovation. And our competitive compensation package and support of a healthy work-life balance all add to a best-in-class employee experience. We are changing lives for a living. Are you ready to make a difference?

 

The Position

Responsible for planning, managing and execution of statistical programming deliverables in clinical trial and non-trial activities in the project. Responsible for providing input to authority required documents or meetings for trial and non-trial activities. Responsible for ensuring that clinical trial and non-trial tasks are aligned with the project specifications.

 

Relationships

This individual contributor reports to the IL Prog and/or the Director of statistical programming. Collaborates closely with the trial squad/working group, often under strict deadlines. Collaborates closely with other programmers re. the programming needed for the trial. Act as point of contact for programmers from the CMRs regarding the programming needed for the trial. Able to explain technical issues to peers and align tasks with stakeholders. Act as point of contact for programmers from the functional suppliers regarding the programming needed for the trial. Occasionally presents statistical programming issues at external conferences and seminars.

 

Essential Functions

• Responsible for planning, managing and execution of statistical programming deliverables in clinical trial and non-trial activities in the project
• Responsible for providing input to authority required documents for the trial and non-trial activities
• Responsible for ensuring that clinical trial and non-trial tasks are aligned with the project specifications
• Responsible for continuous development of own skills and to contribute to the development of Biostatistics
• Responsible for planning, managing and execution of statistical programming deliverables in clinical trial and non-trial activities in the project
• Provide programming input to the setup of the trial, including but not limited to the CRF, Trial Validation Plan and Data Flow Plan
• Ensure that mock TFLs are created and reviewed by stakeholders
• Make AdaM programming according to industry standard and Novo Nordisk (NN) specifications
• Ensure that programming, also by co-workers and functional suppliers, is done according to specifications
• Ensure that the inspection readiness documentation is updated at all time during the trial life cycle
• Responsible for providing input to authority required documents or meetings for trial and non-trial activities
• Create output and provide programming input to the Risk Management Plan, the Investigational Brochure as well as the DSUR/PSUR
• Ensure that relevant programming output and documentation is uploaded or made available for public disclosure, e.g., ClinicalTrials.gov and EudraCT
• Provide programming input to submission related documents, e.g., BIMO, ADRG and summary documentation
• Contribute with programming input in the preparation for meetings with regulatory authorities
• Responsible for ensuring that clinical trial and non-trial tasks are aligned with the project specifications
• Responsible for creating and gathering input to the Specification ADRG for the clinical trial, and ensuring it is aligned with the Project ADRG

 

Qualifications

• Bachelors degree or equivalent ce