Senior Principal Statistical Programmer

Accountable for working with the Project Statistician, other project team members and key decision makers to proactively plan project level activities and for managing continuous process improvements.

Ensure that the planning and management of outsourced statistical programming owned deliverables are effectively performed and are conducted to the highest quality and in a timely manner.

Aid the CRO with prioritization of work when necessary to meet business needs.

With direction, responsible for ensuring technical readiness for a submission (i.e. that all relevant documents are available and in an e-submission ready format and that all internal and external CDISC and regulatory guidelines requirements are fulfilled), inspections/audits (e.g. ensuring appropriate documentation and traceability according to process and standard tools).

Ensure relevant standards are applied consistently.

Ensure maximization of global integratability and interpretability of data. Coordinate with Data Management and Clinical Operation to target high quality databases and specifications at project level.

Work closely with colleagues in interface roles (e.g. Project Data Manager, Project Statistician), to ensure smooth and efficient running of the project.

Efficiently perform (and direct teams to perform) complex trial and project level programming tasks, from set up to project close, with all tasks to high quality and efficiency.

Able to quickly and effectively integrate into different project teams as needed.

Participate effectively on clinical trial teams and as an ad-hoc member on clinical development teams.

Accountable for ensuring statistical programming deliverable timelines and quality expectations are met and best practices implemented. Ensures appropriate level of CRO interaction and surveillance.

With some supervision lead Statistical Programming / Biostatistics initiative teams as required. Develop objectives, milestones, project plan. Monitor progress against the plan and seek guidance and direction as needed.

Location - Bangalore OR HYD

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

North America Disclosure The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

Notice on Fraudulent Job Offers Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information .

Job Segment: R&D, Programmer, Neurology, Oncology, Research, Technology, Healthcare