Senior Statistical Programmer
3 days left
- Experience Level
- Experienced (non-manager)
Senior Statistical Programmer
Location: UK or Netherlands
PRA and our employees have won numerous awards and accolades in the CRO industry and 2020 hasn’t been any different with gold winners in the Project Manager and Clinical Research Team of the Year at the Pharma Times awards! We have won multiple awards across Europe, The America’s and Asia Pacific including BioPharma Asia/Phar-East Best CRO, Pharma Times Clinical Company of The Year and special recognition at the Vaccine Industry Excellent Awards.
As a Senior Statistical Programmer, you will be dedicated to one of our global clients working within medical devices. A company who creates solutions that transform the delivery and experience of care. Encouraging innovation, individuality and embracing people that want to be a part of it.
Working within the embedded program you will ensure efficient data processing for the purpose of research (particularly regulatory and marketing claim substantiation, during clinical evaluations, studies, and trials) is high quality and in compliance with regulatory body standards. The function is part of Global Biostatistics and Data Management within Clinical and Medical Affairs.
Key responsibilities in this role include:
- Review CRFs and database specifications to ensure consistency with the study protocol and for the purpose collecting the data to meet the objectives defined in the statistical section of the clinical study protocol and Statistical Analysis Plan.
- Create analysis datasets from the clinical database and other data sources as outlined in the clinical study protocol and Statistical Analysis Plan.
- Generate tables, listings, and figures as specified in the Statistical Analysis Plan.
- Create ad hoc analyses and summaries as requested.
- Provide data cleaning support for the data management effort.
- Develop standardized SAS macros and utilities.
- Involved in the QC of all the deliverables created by programming and statistics (e.g. analysis data sets, output, the statistical section in the study report).
- Works under the guidance of the project Biostatistician.
- Build successful relationships and seamless interfaces at the protocol / project team level, and provide timely and effective communication to the study team / trial manager and Biostatistics leads.
- Provide input for the technical infrastructure of the statistic programming function.
- Develop and implement strategy for the improvement of productivity and standardizing of statistical programming activities.
- Assist in developing, applying and promoting consistent standards through standard processes and SOPs.
- Ensure guidelines and specifications regarding programming practices are followed, and ensure maintenance of appropriate documentation regarding lead and validation programming efforts.
- Interface closely with Biostatistics and Data Management on the project lev
- Able to work independently.
- The ability to travel up to 15% of time.
- Other Duties as assigned.
- BS Degree in Computer Science, Information Management, Mathematics, Statistics, or a scientific discipline; or sufficient relevant experience with 0-3 years of Statistical Programming knowledge in the device / pharma industry.
- Extensive experience with Base SAS, SAS/STAT, SAS Macro language, SAS/GRAPH, and in general excellent computer skills.
- Coding dictionary experience preferred.
- Strong communication skills, both verbal and written.
- Strong scientific background and understanding of clinical trials, pharmaceutical / device operations, and regulatory compliance.
- Practical knowledge of ICH, FDA, and GCP regulations and guidelines.
- Proven ability to take independent action to initiate process improvement, when needed.
- Proven ability to work in a matrix-like manner where cross-functional interaction is implicit.
- Proven ability to deliver on delegated work efficiently.
- Solid time-management skills to meet deliverables commensurate with a fast-paced environment.
- Well organized, able to multitask and prioritize competing tasks.
- Able to manage expectations with supervisors, peers and customers.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
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