Manager, Statistical Programming
JR000009871 Manager, Statistical Programming (Open)
US Specialty Brand Headquarters - USA501
The Manager, Statistical Programming is responsible for assigning tasks and assessing the quality of Statistical Programming deliverables to ensure effective support of clinical trial programs. Deep knowledge and hand-on skills in SAS and other programming tools and understand how various technologies which can be utilized and facilitate programming development. Interact with internal and external functional leads for alignment and provide updates to supervisor. Involve in the development of CDISC standards and SOPs related to the Statistical Programming function and ensures adherence.
- Train and manage employees and consultants within area of responsibilities.
- Participate in budget and resource planning for clinical trial and adhoc requests related to the Statistical Programing deliverables.
- Partner with Clinical Application and Database groups in developing and maintaining infrastructure of the programming environment.
- Responsible for the study and adhoc request timeline and quality of Statistical Programming deliverables.
- Establish and negotiate timelines with internal and external team members for completion of activities for a project.
- Develop, apply, manage and promote consistent programming standards, e.g. logic, coding, testing, and updating, through standard processes, SOPs/WIs and methodologies.
- Maintain appropriate documentation surrounding retaining or archiving clinical data and/or programs.
- Follows regulatory requirements and guidelines for the development, usage, and maintenance of programs to support regulatory submissions.
- Lead the group to design robust, flexible, and modular macros and implement across various projects.
- Interacts with other functional areas to resolve issues pertaining to duties assigned or requested technical consultation.
- Conduct oversight management of vendors and assess the quality of clinical trial information (i.e. data sets, tables, listings, graphs, etc) provided in support of clinical trial submissions to regulatory authorities.
BS or BA Degree in Computer Information System, Computer Science, Mathematics, Statistics, or a related field
10 years of SAS programming experience in scientific/research field, with a minimum of 3 years of experience in supporting regulatory submissions (NDA, BLA, IND, BA\BE or Global Equivalents), and a minimum of 3 years of managing direct employees.
- In-depth knowledge of CDISC SDTM, ADaM, Define.xml, CFR 21 Part 11 compliance, ICH and FDA standards preferred.
- Strong knowledge of BASE/SAS, SAS Macros, ODS and SAS/Graph in a Windows SAS environment.
- Knowledge of data manipulation, report generation in support of regulatory submission.
- Understanding of data and system dependencies, validation techniques, and integration of studies for ISS/ISE.
- Knowledge of the Software Development Life Cycle (SDLC) and methodologies.
- Knowledge of MS-Office (i.e. Word, Excel and PowerPoint)
- Technical writing skills adequate to prepare effective documentation for programs and contribute to SOP development.
- Effective interpersonal skills in collaborating with teams composed of individuals with widely diverse backgrounds, skill levels, and organizational levels