Director Biostatistics

Job description
Role – Director – Biostatistics and programming

Educational qualification: Requires a Master’s Degree/Bachelor’s Degree in Mathematics, Statistics, Engineering, Computer Science/Applications , Biostatistics or Pharmacy

Professional Qualifications
• 15+ years of experience with 10 years of leadership experience on multiple projects in clinical programming domain.
• Should be experience in handling large size teams (minimum 50 members )
• Knowledge of CDISC SDTM and ADaM models and data mapping process is desirable.
• PMP Certification or equivalent preferred.
• Exposure to work on clinical trials pertaining to at least one Therapeutic area would be preferrable

Job Roles and Responsibilities

1.Responsible for technical strategies and support for the programmers and analysts across the function.

2.Provide leadership/expertise in resolving complex problems in support of division/company objectives, or assigned projects.

3.Represent the company and the statistical programming department in customer development and liaison.

4.Manage sponsors and vendor relationship. Participate in regular and ad hoc management meetings with clients.

5.Provide leadership expertise in statistical programming methods and techniques in support of ongoing projects and with clients.

6.Participate in new business development and bidding processes while driving the RFI/RFP process

7.Interact with regulatory agencies and support sponsor company in new drug application.

8.Carry out functional management responsibilities for assigned staff, including Performance Management and Development activities, disciplinary procedures and administrative activities.

+.Encourages staff career growth and development.

11.Mentor and evaluate team members to establish training and coaching needs.

12.Work closely with leads to ensure that staff resources are used efficiently, and team is optimally utilized.

13.Develop statistical programming performance requirements and measurements according to the corporate standards. Perform ongoing assessment/measurement of project team performance against set standards.

14.Perform quarterly, semi-annual and annual performance review and development plans for direct subordinates and, where appropriate, indirect subordinates.

15.Proactively lead, review and amend departmental processes and documentation.

16.Oversee and drive the development of a Project Plan, develop and monitor timelines for statistical programming activities for all dept specific projects

17.Participates in internal and client audits, and regulatory inspections.

18.Keeps abreast of new statistical programming practices, methods and tools, regulatory practices, and industry trends to stimulate departmental growth

1+.Manages discretionary expenses and spending within team in order to meet budget

20.Serve on the management team at the corporate level ensuring divisional needs and concerns are represented.