Senior Statistical Programmer

Job Description

Responsibilities

Technical:

• Perform consistency review of clinical trial documents including protocols, SAPs, CRFs, CSRs
• Author and review simple and complex study TFL shells
• Author and review simple and complex dataset standards
• Perform data checks and data exploration (e.g. using frequencies, histograms)
• Program and QC routine and ad hoc datasets and TFLs (in SAS) following specifications, applying good programming practice
• Complete and review CDISC Validation tool reports
• Ensure the appropriate standards are being applied and adhered to
• Familiarization with simple statistical techniques (e.g. t-test, ANOVA, regression, standard survival)
• Review of project management related documents
• Maintain study master file documents and any other documents that are required to be audit ready

General:

• Lead internal and client study team meetings effectively
• Present study updates internally and at client meetings
• Share scientific, technical and practical knowledge within the team and with colleagues
• Perform work in full compliance with applicable legislation, regulations, company policies, procedures, and training
• Build effective collaborative working relationships with internal and client team members
• Seek opportunities to develop innovative ideas, sharing when appropriate
• Line management or mentorship of more junior team members
• Contribution to development of internal training materials
• Contribution to internal process improvement initiatives

Qualifications

• Degree in a relevant field such as Mathematics, Life Sciences, Statistics, Computer Science, etc.
• At least 5+ years of relevant industry experience

Required Skills

• Understanding of clinical drug development process, relevant disease areas, endpoints and study designs
• Strong SAS programming skills with SDTM, ADaM, and TFL development experience
• Good knowledge of CDISC standards and clinical trial processes
• Experience reviewing protocols, SAPs, CRFs, and CSR documents
• Hands on experience in R Programming.
• Proficiency in data handling using SAS or other statistical software (e.g. R)
• Awareness of industry and project standards & ICH guidelines
• Demonstrated problem solving ability and attention to detail
• Ability to work independently and as part of a team
• Excellent verbal and written communication skills
• Interpersonal/teamwork skills for effective interactions
• Self-management skills with a focus on results for timely and accurate completion of competing deliverables

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