1. Leads, manages and supports the Biostatistics (Statisticians as well as Statistical Programmers) team in all project deliverable tasks including project timelines, resourcing, and budgetary planning.
2. Supervises Biostatistics and Statistical programming staff.
3. Assists in the development and refinement of existing departmental processes.
4. Line management of staff including: performance management, progressive discipline, and training need identification.
5. Recommends courses of action on salary administration, transfers, new hires, terminations, and professional development.
6. Regularly communicates with staff on working practices, policies, and work instructions. May develop internal training in new technology and industry methods.
7. Assigns project work and reviews workload for all direct reports.
8. Manages staff by establishing goals to increase knowledge and skill levels and by delegating tasks commensurate with skill level.
9. Assists with developing, monitoring, and enforcing productivity and quality standards. Assists with project and timeline metrics and monitoring.
10. Assists in the development of programming process and procedures, SOPs, and refinement of existing processes.
11. As a senior member of the Biostatistics department, provides senior review of outgoing deliverables and creation or review of setup specifications.
12. Serves as Statistical Programming representative for sponsor meetings, kickoff meetings, audits and, etc.
13. Interacts with and serves on project teams. Coordinates and leads development activities for projects. Accepts unique and new assignments, works independently and completes work on time.
14. Attends meetings, participates in discussions, uses an analytical approach to problem! solving, focuses on deliverables, and provides constructive c! riticism . Keeps those responsible for project management informed of any issues that might impact project target dates, scope or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources.
15. Builds positive departmental and inter-departmental relationships. Provides leadership, training, guidance and support to other department members.
16. Involved in other company activities where statistical services are required, such as global and full development programs.
17. Provides scientific consulting in the design of drug development.
18. Collaborates in protocol development as required (completing statistical section of protocols). Writes and reviews protocol analysis plans and mocks table shells. Prepares and submits ICH and regulatory dossiers.
