Principal Statistical Programmer

Key Skills

Java Programming, Python Programming, C++, C Programming, SQL, Cloud computing, Scala Programming, Machine learning techniques, Data science techniques, MATLAB Programming, PyTorch, TensorFlow, R Programming

Job Description

This is a lead position in providing statistical programming expertise and in planning, executing, and analyzing of clinical studies in the Interventional Cardiology therapeutic area, such as heart valves, LAAC, coronary stents and balloons.

This position offers an opportunity to expand your knowledge and skill sets in a collaborative environment that encourages showcasing your talent and progression into areas of advanced statistical programming (eg Bayesian methods, adaptive designs), novel medical devices, and interactions with various internal and external stakeholders as well as managing CROs.

Your responsibilities will include:

• Prepares statistical report templates, data specifications, and analysis datasets (ADS). Develops statistical programs using SAS® for statistical analysis and generating report (TFLs) for internal and external projects and maintains programming documentation as appropriate.
• Performs quality control and validation according to departmental processes and procedures. Ensures analysis performed in accordance with applicable statistical methods and in compliance with regulatory and company standards.
• Leads and collaborates with internal or external team members (e.g., Statisticians, Medical Writers, Medical Directors, and Physicians), such as leading the activities for data integration and evidence generation, regulatory submission, study data publications, interpretation of analysis results.
• Works with Biostatisticians and cross-functional team members to develop study design and analysis plan as needed. Leads studies and applies functional expertise, such as review of CRF, Statistical Analysis Plan, Study Protocol, Clinical Study Report, and other relevant study plans and timelines. 
• Leads activities as required for the position, such as continuous programming process improvement including standardization and updates on new technical skills and regulatory and industry requirement and trends related to statistical programming.
• Interfaces as Subject Matter Expert and acts as coach and mentor with vendors performing functional tasks.
• Responsible for determining, implementing and executing CRO oversight plans and activities for outsourced statistical and programming work. Manages CRO's performance as a functional lead.

Required qualifications:

• Bachelor’s degree or higher in computer science, mathematics, statistics, biostatistics, or related field
• 8+ years of clinical data analysis experience using SAS® in medical device, pharmaceutical or healthcare industry 
• In-depth knowledge of SAS® programming language and common statistical methods/tests. Proficient in SAS® Macro programming, ODS/RTF, ODS/GRAPH. Extensive working experience using various SAS/Stats Procedures (e.g., Logistic, GLM, Phreg, and Lifetest).
• Attention to detail with excellent problem-solving skills
• Self-motivated and ability to proactively identify and address issues
• Ability to intact and communicate with people effectively and to explain statistical methods and results clearly as well as strong experience working in a team in a global and remote context
• Solid experience overseeing and managing CRO work and performance 

Preferred qualifications:

• M.S. degree with 8+years experience
• Experience with sample size calculation and simulations
• Experience with Bayesian design and analysis, adaptive design, survival analysis
• Familiar with other statistical programming package or software, such as R, WinBugs, East, etc.
• Experience of presenting statistical methods or programming technics in major statistics or programming conferences
• Experience of Common Data Model (CDM) or related data model and database structures
• Experience of data mining or data science related to clinical studies