Publish Date: 02/05/2021 This position is responsible for applying advanced programming techniques to support the development and validation of statistical programs to be used for monitoring, analyzing and reporting of clinical trials data for regulatory submissions and publications across multiple disease areas ESSENTIAL DUTIES AND KEY DELIVERABLES: • Adheres to departmental procedures and practices, technical and industry standards and programming concepts and conventions during all aspects of work • Applies advanced level programming techniques to the planning, implementation, and maintenance of software for the monitoring, reporting, and analysis of clinical trials • Develops complex SAS programs that develop models to analyze and tablulate clinical study reports in line with CDISC (Clinical Data Interchange Standards Consortium) SDTM (Study Data Tablulation Model) format • Writes statistical programs using SAS to implement statistical analyses (i.e., generating tables, listings, figures, and inferential statistical output) supporting regulatory requests, ISS/ISE analyses, commercial requests, biostatistical ad-hoc analysis • Serve as lead statistical programmer to be responsible for the timeline and quality of all statistical analysis deliverables • Conducts statistical program verification, identifies bugs and resolves technical problems • Uses statistical tools like SAS to solve complex statistical programming problems • Works closely with Biostatisticians to create analysis files specifications and analysis outputs following the instructions provided in Statistical Analysis Plan (SAP) • Identifies problems and develops global programming tools that increase the efficiency and capacity of the Statistical Programming group (e. g. , macros) • Performs SAS programming using more complex techniques such as SAS macro language, advanced data manipulation techniques, and statistical procedures (e.g., PROC GLM, PROC FREQ, PROC REPORT) • Troubleshoots and provides quality review of complex SAS programs • Responsible for maintaining excellent working knowledge of clincal data, the design and phases of clinical trials, statistics, relevant regulatory requirements, and the pharmaceutical industry • Assists in the preparation and distribution of reports to the project team members • Works effectively with cross functional groups within Biometrics and the clinical study team • Participates in monitoring CRO activities and reviewing CRO deliverables as necessary • Participates in the development of standard reporting tools for the statistical programming group • Contributes to developing Biometrics SOPs and guidelines • Contributes in the development, implementation and documentation of programming standards, templates and conventions, including potential implementation issues • Works with pre-clinical and clinical research staff to plan and query results for studies to support global development plans • Contributes to the implementation of CDISC standards for Santen studies • Serves as a Subject Matter Expert (SME) in Statistical Programming and mentors junior programmers • Serves as an expert troubleshooter QUALIFICATIONS: • MS in Statistics, Health informatics, Biostatistics, or Computer Science required. • Experience with SAS programming with emphasis in Pharmaceutical clinical trials. • SAS Programmer certification required. • Strong understanding of clinical trial data and extremely hands on in data manipulation, analysis and reporting of analysis • Advanced knowledge of Base SAS including data steps, PROC’s, SAS MACRO and SAS GRAPH • Advanced knowledge of SAS/STAT statistical software • University level data management/statistics course(s) or equivalent experience in datamanagement/statistics • Ability to interpret tabular and graphical clinical data presentations • Knowledge and application of p-values, confidence intervals, regression analysis, advanced general linear models including repeated measures models, survival analysis, non-parametric analysis, randomization, and proficiency in implementing these ideas in clear, efficient SAS code • Experience with Electronic Data Capture (EDC) and some Clinical Data Management packages (Oracle Clinical or equivalent clinical EDM system) and relational database theory • Preferred experience working on FDA submissions • Preferred hands-on experience implementing SDTM and ADaM data standards • Able to give effective presentations to small groups such as project teams • Ability to effectively influence others • Ability to independently make high-level decisions • Strong cross-functional collaboration skills and ability to work with culturally diverse team members • Excellent verbal, written, organizational skills Please refer our Referral Policy Are you creative & innovative? Do you enjoy developing and implementing solutions to fascinating business problems? If you do, consider joining our team. At TEKaroon, our most valuable resource is the knowledge and expertise of our people. We encourage both personal and professional growth. TEKaroon provides global opportunities along with a very competitive salary and benefits package. We also collaborate with our employees in the never-ending process of skill and professional enhancement. At TEKaroon, you will be entering in an environment of extraordinary innovation and unprecedented growth. You will be surrounded by a diverse community of enthusiastic, bright colleagues who share a distinctive culture of teamwork and knowledge. If you thrive on challenge and seek an environment where you can make a real difference, send us your resume to [email protected]