Statistical Programmer II

Job Description:

Job Title: Statistical Programmer II

Job Location: Trivandrum,India

Job Overview:

The Statistical Programmer II is responsible for programming activities for the data preparation and analysis of clinical data. Duties include creation and validation of datasets, tables, listings and figures according to the project specifications.

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 Caidya and/or clients as appropriate.
  • Generation and review of dataset specifications
  • Development and documentation of programs used to generate datasets
  • Development and documentation of programs used to generate listings, tables and graphs
  • Program validation including generation of validation documentation
  • Data preparation and documentation according to CDISC data standards
• Intense and cross functional interaction with other members of the project team
• Perform all programming work in accordance with the Caidya SOPs
• Design, development, documentation and validation of tools and macros to continuously improve quality and efficiency of processes applied
• Training of group members on new processes, programs etc. as appropriate
• Initial Training on existing processes, programs etc. for new group members

Supervisory Responsibilities:

No supervisory responsibilities

Job Requirements:

Education

• BSc, MSc or equivalent experience in information technology, mathematics, statistics or life sciences

Experience

• Minimum of 3 years’ experience in processing and analyzing clinical trial data or demonstrated aptitude for statistical programming work
• Minimum of 3 years’ practical experience in the use of a SASwith 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
• Sound knowledge of the SAS programming language
• Knowledge of relevant regulatory requirements
• Knowledge of medical terminology and conduct and analysis 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.

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