Responsibilities:

• Communication with the sponsor and other collaborators of the project regarding data management issues.
• Production and Maintenance of key study related documentation (Data Management Plan, Data Validation Plan, EDC specifications, Data Management Report) according to standard operating procedures.
• CRF design and review determining the data collection requirements of the study through review of the protocol and other supporting documentation.
• Creation of the edit-checks included the Data Validation Plan as well as the listings and reports as agreed with the sponsor.
• Coordination of all data cleaning activities including DCF/query handling and coding management.
• Coordination of external data transfer, integration and reconciliation with the study database.
• Coordination and finalization of database lock activities in close collaboration with the sponsor, statistician and other parties.
• Development of standardization (templates and processes).
• Coaching of more junior staff

Experience:

• University degree, preferably in science
• Thorough knowledge of the Data Management process
• Minimum 5 years of successful Clinical Data Management experience
• Experience in EDC systems set-up is required
• SAS programming knowledge and experience is useful
• CDISC standards knowledge is beneficial for the position
• Excellent organizational and communication skills

Education:

• Bachelor’s Degree, B.S. preferred

Skills:

• Strong computer and analytical skills
• Good written and verbal communication skills
• Fluent in English
• Ability to set priorities and respect tight deadlines
• Problem solving skills, team player

Job responsibilities include:

• Responsible for development of statistical methodology for analysis of study data.
• Responsible for Statistics’ deliverables within assigned projects.
• Perform QC of others team members work.
• Statistical analysis of study data and related decision-making.
• Responsible for statistical input to statistical reports and Study Reports.
• Provide statistical representation on multi-disciplinary team preparing protocol; responsible for statistical input.
• Supervision of less-experienced statisticians within project activities.
• Project management activities for identified projects including resource planning and utilization, timelines and milestone management.
• Take responsibility for overall status and quality of Statistics’ project documentation, including maintenance of hardcopy and electronic files.
• Provide statistical input into other disciplines’ activities and participate in interdepartmental processes.
• Review statistical content of computer validation deliverables.
• Independent peer review of statistical deliverables, e.g., protocols, Summaries and Individual Data Listings, statistical reports, Study Reports.
• Provision of technical solutions and advice to Covance staff and to clients on statistical methodology and principles.
• SAS programming and related activities for the presentation and analysis of study data.
• Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team.
• Liaising with external clients over specific requirements.
• Assigned tasks related to the development of less-experienced staff within the department.
• Contribute to review and amendment of departmental processes and supporting documentation.
• Contribute to proposals activities and client presentations.
• Represent the department during project-driven client audits.
• Conduct all work in compliance with applicable regulatory requirements, and specifically those regulations (GxP) specified in the study plans, protocols, or work agreements governing the work in which they are involved.

Education/Qualifications:

• PhD, MA or MS in statistics subject, preferably with a strong medical statistics component. (Alternative academic qualifications are assessed for comparability.)

Experience:

• 3 to 5 years of postgraduate experience in the application of statistics in the pharmaceutical environment for employees with a PhD in statistics subject; 5 to 8 years of postgraduate experience in the application of statistics in the pharmaceutical environment for employees with an MA/MS in statistics subject
• Effective interpersonal and communication skills.
• The ability to work to tight deadlines while maintaining high standards.
• SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, mixed models, non-linear models, survival-adjusted tumour incidence models and survival analysis.
• Ability to adhere to strict guidelines & codes of practice.
• A good knowledge of overall drug development process.
• Experience in the preparation of statistical methodology, analysis, reporting, etc.
• Ability to explain statistical concepts to non-statisticians.

Well established international contract research organization serving both commercial as well as government markets, is conducting a search for a SAS Programmer.

Responsibilities:

• Responsible for converting datasets to SDTM standards.
• Designs ADaM datasets and variables.
• Experienced in writing SDTM specifications and annotations.
• Serve as mentor to other developers with less CDISC expertise.
• Map and convert raw clinical data sets to CDISC SDTM compatible data sets.
• Validate CDISC SDTM and ADaM data sets by using Open-CDISC Validation Tool.
• Create data definition documents for CDISC SDTM and ADaM datasets and other electronic submission components.
• Produce tables, listings, and figures for the clinical study report (CSR).
• Convert legacy clinical trials data to CDISC data format.
• Manage time effectively. Accurately estimate effort for tasks and meet agreed-upon deadlines. Effectively manage ad-hoc requests and multiple deadlines. Identify opportunities for automation, improved efficiency and reuse.
• Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations. Respond promptly to requests from Validation/Test team for documentation or bug fixed.

Requirements:

Bachelor’s degree in a related field and 4+ years CDISC, SDTM and ADaM experience required inclusive of creating derived data sets. Must have strong SAS programming skills and solid working knowledge of CDISC standards. Experience in the CRO and/or pharmaceutical industry is preferred. Knowledge of database mapping tools and experience with biostatics in clinical trials are highly preferred as well.