The Senior Statistical Programmer is responsible for all aspects related to programming activities for the data preparation and analysis of clinical data. Duties include creating all datasets, tables, listings and figures according to the specific project Statistical Analysis Plan (SAP) as well as coordinating Quality Control efforts and implementing all programming required for study/project completion
BSc, MSc or equivalent experience in information technology, mathematics, statistics or medical documentation; Minimum of 5 years experience in processing and analysing clinical trial data or demonstrated aptitude for statistical programming work; > 3 years practical experience in the use of a statistical software package (like SAS or R) with respect to all aspects of software development and validation
Back to Search Results Senior Statistical Programmer (Remote) Clinipace is a global full-service clinical research organization (CRO) serving the unique needs of venture-backed, mid-tier and strategic pharmaceutical, biotechnology and medical device firms. We help our customers advance drug candidates to deliver successful stakeholder and patient outcomes. We leverage extensive therapeutic knowledge, clinical trial expertise, and comprehensive innovative technology to support life science firms in achieving some of their most important goals: Executing regulatory strategies, optimizing clinical development timelines and completing high quality trials. We are proud to have a culture that is vibrant, supportive, performance-driven, and passionate while focusing on continual learning and development. Clinipace associates are passionate about their lives and bring that same passion to their work at Clinipace. Work Location: France | Paris Job Code: S4958 Description Job Title: Senior Statistical Programmer (Remote) Job Location: France - Paris (Home-based, other locations considered) Job Overview: This position is a remote, home based opportunity, anywhere in France. The Senior Statistical Programmer is responsible for all aspects related to programming activities for the data preparation and analysis of clinical data. Duties include creating all datasets, tables, listings and figures according to the specific project Statistical Analysis Plan (SAP) as well as coordinating Quality Control efforts and implementing all programming required for study/project completion. Job Duties and Responsibilities: Development and documentation of programs used in the production of computer generated outputs for clinical study reports, registration and submission documents, publication requirements plus any other document used to present clinical trials data, e.g. answers to requests from health authorities, individual sponsors requests, scientific papers and conferences, etc. in line with existing regulatory guidelines, industry standards and standard operating procedures issued by Clinipace and/or clients as appropriate. Conception and generation of dataset specifications Design of integrated databases and development of mapping specifications for integrated datasets Data preparation and documentation according to CDISC data standards Program validation including generation of validation documentation Development and documentation of programs used to generate listings, tables and graphs Development and documentation of programs used to generate datasets Preparation of electronic submission of clinical data Intense and cross functional interaction with other members of the project team Providing internal consultancy in various review activities like database design, data validation rules, analysis plans, table shells etc. Interaction with clients Design, development, documentation and validation of tools and macros to continuously improve quality and efficiency of processes applied Writing of User Manuals Training of group members on new processes, programs etc. as appropriate Initial Training on existing processes, programs etc. for new group members Attending and representing the company at business conferences Participation in industry working groups Coordination of allocated teams of Statistical Programmers assigned to a specific client project including the monitoring of workload, estimation and forecast of resource needs within the specific activity and responsibility for coaching and education of other team members. Coordination of internal projects for continuous improvement of processes and systems Supervisory Responsibilities: N/A Job Requirements: Education BSc, MSc or equivalent experience in information technology, mathematics, statistics or medical documentation Experience Minimum of 5 years experience in processing and analysing clinical trial data or demonstrated aptitude for statistical programming work > 3 years practical experience in the use of a statistical software package (like SAS or R) with respect to all aspects of software development and validation Skills/Competencies Highly developed analytical skills, team player qualities (knowledge, skills, personal qualities) Fluency in English Expert knowledge in SAS Knowledge of relevant regulatory requirements Knowledge of medical terminology and conduct and analysis of clinical trials Knowledge of different indications of clinical trials Knowledge of industry data standards (e.g. CDISC SDTM and ADaM) Capabilities Team player: Shows support for teamwork, cooperation, self-control, and flexibility to get the job done. Comfortable working under supervision and as part of a team. Practices professionalism and integrity in all actions. Demonstrates honesty, trust and fairness. Strong written and verbal communication skills #LI-IM1 The company will not accept unsolicited resumes from third party vendors. Are you a returning applicant? Previous Applicants: Email: Password: If you do not remember your password click here. New Search
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