Manager, Programming

Role Summary

The Manager, Programming will provide statistical programming and analytic support for clinical studies. As a member of the Programming function, the role collaborates with Biostatistics, Clinical Operations, Data Management and Project Management, as well as external vendors.

Responsibilities

• Represents programming function in Study Team meetings and interacts with functional colleagues from other departments.
• Stay abreast of latest techniques in SAS Programming and CDISC Standards and continually improve internal processes to gain efficiency and regulatory compliance.
• Develop complex SAS Macros to reduce redundant programming and increase efficiency in projects.
• Motivate and mentor SAS Programmers to complete assigned deliverables.
• Lead study/initiatives and utilize resources to meet corporate objectives.
• Create specifications for data transformation in accordance to SDTM IG and SAP.
• Creation of CDISC compliant deliverables - SDTM & ADaM datasets, annotated CRF (aCRF), define.xml, reviewer guides (SDRG/ADRG).
• Perform statistical analysis, generate analytic reports, tables, figures, and slides in support of clinical study and other reports.
• Professional development to enhance knowledge, skills, communication, scientific methodology, operational efficiency, and compliance with policies, regulations, and corporate standards and processes.

Qualifications

• Requires a Bachelor’s degree or higher in Statistics, Computer Science, Mathematics, Engineering or related field of study.
• Master’s degree or higher in Statistics, Computer Science, Mathematics, Engineering or related field of study is a plus.
• Minimum 5-7 years of work experience in a pharmaceutical/biotech (preferred) or related industry.
• Solid programming background and advanced SAS programming skills required.
• Prior experience in leading studies/projects is required.
• Prior experience in line management (direct reports) is a plus.
• CDISC experience in SDTM/ADaM/Define.xml standards are required.
• Prior submission experience is highly preferred.
• Other statistical software knowledge is a plus (R, S-Plus, WinBugs, etc.).
• Programming skills or experiences with VBA, C++, Python, etc. are helpful.
• Must have good communication skills (verbal and written).
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
• Ability to interact successfully in a dynamic and culturally diverse workplace.