Purpose:
The Associate Director - Statistical Programming takes lead during the development of data
analysis plans in collaboration with statistical colleagues, physicians, and/or medical
colleagues. The Associate Director - Statistical Programming is responsible for establishing a
reporting database and for analyzing clinical trial data by working with clinical research
associates/clinical development associates and project statisticians. In addition, the Associate
Director statistician-computation will provide coaching and guidance to less experienced
staff members.
The job tasks listed below outline the scope of the position. The application of these tasks
may vary, based upon current business needs.
Statistical Trial Analysis
Collaborate with other statistical colleagues and study personnel to provide input to
statistical analysis plans.
Assist in and/or be accountable for selecting statistical methods for data analysis,
authoring the corresponding sections of the data analysis plan, and conducting the
actual analysis once a reporting database is created.
Collaborate with data management in the planning and implementation of data
quality assurance plans.
Maintain proficiency with respect to SAS programming and statistical methodology
and in applying new and varied methods.
Effectively justify methods selected and implement previously outlined analysis plans.
Conduct peer-review of work products from statistical colleagues.
Effectively utilize current technologies and available tools for conducting the clinical
trial analysis.
Utilize deep technical skills to drive solutions to complex design and analysis issues.
Communication of Results and Inferences
Collaborate with other statistical colleagues to write reports and communicate
results.
Responsible for assisting in the communication of study results via regulatory
submissions, and manuscripts, as well as for communicating one-on-one with key
customers.
Assist or respond to regulatory queries working in collaboration with other statistical
colleagues.
Therapeutic Area and Systems Knowledge
Understand relevant disease states in order to enhance the level of customer focus
and collaboration.
Regulatory Compliance
Perform work in full compliance with assigned curriculum(s) and will be responsible
for following applicable Corporate, Medical, local, and departmental policies,
procedures, processes and training.
People Related
Ensure all direct reports have a Performance Management (PM) and Development
plan in place.
Conduct interim and final PM reviews to evaluate performance, business results, and
impact.
Provide appropriate input on consensus evaluation for merit increase and promotion
activities.
Contribute to the development of direct reports through administrative direction,
coaching, mentoring, and timely feedback.
Appropriately manage the workload of direct reports.
Provide input on employee development, talent assessment, and succession planning
activities.
Encourage appropriate rewards for deserving individual/group performance and
results.
Ensure all direct reports are in compliance with company policies, procedures, and
regulations.
Business Related
Perform appropriate staffing activities and support the training and integration of
new and current staff.
Ensure appropriate implementation/execution ofpersonnel/resource management
plans and priorities.
Take lead in identifying the needs and the recruitment of staff to meet business plan.
Take active role in capacity planning and business planning.
