- 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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