Biostatistician

You will be responsible for providing statistical input to the design, analysis, reporting, and interpretation of clinical studies, as well as contributing to publications. Utilize SAS or other software to develop custom programming code for generating tables, data listings, graphs, and derived datasets as specified in the protocol or statistical analysis plan. Ensure that all outputs meet quality standards and project requirements. Perform validation programming and collaborate with other Programmers, Biostatisticians, and project team members to resolve any discrepancies or findings. Keep the project team informed of programming progress and any issues requiring their attention. Adhere to applicable SOPs and relevant regulatory guidelines. Manage scheduling and time constraints across multiple projects simultaneously. Set goals based on management priorities and adapt to timeline or priority changes by reorganizing daily workload. Prepare in advance for internal meetings, contribute ideas, and show respect for the opinions of others. Demonstrate willingness to collaborate with team members, assist with projects, and support initiatives as necessary to meet business needs. Negotiate and establish accurate time estimates for completing study activities with internal team members and statistical management. Ensure completion of project activities within the allotted timeframe. Assist in drafting regulatory submissions and stay updated with current literature and research new methodologies. Identify, develop, and implement novel statistical methodologies to support medicine development. Uphold scientific integrity and animal welfare in all activities. Interact with global statisticians and implement their recommendations locally. Create and maintain standard macros and applications to enhance department efficiency. Actively participate in process/quality improvement initiatives, standardization efforts, and other non-clinical activities. Contribute to mentoring other team members, develop training courses, present training materials, provide feedback, and guide new associates in the process. Engage in knowledge-sharing activities to foster a collaborative work environment.,