Associate Principal Statistical Programmer

Job Overview:
As a Senior Statistical Programmer, you will provide experienced technical expertise to develop process methodology for the department to meet internal and external clients’ needs.
Plan and coordinate the development of integrated programming solutions, serving the full spectrum of statistical programming needs. You will also provide technical expertise and leadership to the department and provide internal consulting services, including specifications and user needs analysis for complex project or client requirements.

Key Responsibilities:

1. Perform, plan, coordinate, and implement the following for complex studies:
   
   • The programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listings.
   • The programming of analysis datasets (derived datasets) and transfer files for internal and external clients.
   • The programming quality control checks for the source data and report the data issues periodically.
2. Interpret project level requirements and develop programming specifications, as appropriate, for complex studies.
3. Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and Statistical Programming department, for complex studies.
4. Fulfill project responsibilities at the level of technical team lead for single complex studies or group of studies.
5. Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines.
6. Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables.
7. Provide training and mentoring to SP team members.

Requirements:

1. 5+ years Statistical Programming experience within the Life Science industry.
2. BSc or MSc degree in Biostatistics or related field.
3. Experience in SAS Base, and good knowledge of SAS graph and SAS Macros.
4. Ability to implement more advanced statistical procedures as per specifications provided by Biostatistician.
5. Excellent knowledge of CDISC standards (SDTM and ADaM).
6. Thorough understanding of relational database components and theory.
7. Excellent application development skills.
8. Strong understanding of clinical trial data and extremely hands-on in data manipulations, analysis, and reporting of analysis results.
9. Ability to work on multiple projects, plan, organize and prioritize activities.
10. Experience as technical team lead directly engaging clients and coordinating tasks within a programming team.
11. In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.