Develop and review SAS specifications, programs and output for the creation of ADaM and client defined analysis datasets, tables, listings and graphs in support of statistical Analysis plans.
- Interact with project team members in related discipline e.g. Clinical data management, Clinical Operations and Biostatistics.
- Assume team member responsibilities, including representing Statistical programming at internal project team meetings and with support from statistical programming staff at client meetings.
- Demonstrate good problem solving skills, a proactive approach and a willingness to make decisions, seeking advise from senior Statistical programming staff at client meetings.
- With sufficient experience assume the role of a Lead Programmer for assigned projects.
- Understand scope of project in order to advise Senior statistical programming staff of changes in scope of projects to enable the timely development of change orders.
- Assist with training, mentoring of statistical programmers under the supervision of senior statistical programming staff.
- Participate in statistical programming review of case report forms, annotated CRFs, database structure and study related documentation.
- Review draft and final production runs for projects to ensure quality and consistency.
- Ensure the filing of study documentation is maintained to the standard requirement according to processes and accpetable for audit.
- Prioritize personal workload to meet specified completion dates.
- Carry out all activities according to Covance SOPs working within the framework of the Quality management system and to Good Clinical Pratice (GCP).
- Perform other duties as assigned by Senior Statistical Programming staff.
Graduate or Bachelor’s degree in Life Sciences (or Pharma or related health discipline) from an accredited university or college.
BSc, B.E , B.Tech, M.Tech, preferably in computing, life science, mathematical or statistical subject
3-7 years experience as Statistical Programmer for amnagement and reporting of clinical trial data.
- Demostrated skills in the use of SAS.
- Good time management skills and the ability to work to tight deadlines while maintaining the highest standards of work.
- Awareness and appreciation of the business needs of a CRO.
- Effective communication skills.
- Cooperative and team oriented approach.
- Self motivation and ability to work independently.
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