Statistical Programmer II

Caidya; Thiruvananthapuram; Hybrid; INR 1,200,000 - 2,000,000; Full time

Job summary

Caidya is seeking a Statistical Programmer II to handle programming activities for data preparation and analysis of clinical data. Responsibilities include creating and validating datasets, listings, tables and figures as per project specs.

You will develop and document programs for outputs used in study reports and regulatory submissions, while maintaining CDISC SDTM/ADaM standards. Strong SAS skills, English fluency, and regulatory knowledge are essential.

Qualifications

• Essential: degree in IT, math, statistics or life sciences.
• Minimum 3 years’ experience in processing and analyzing clinical trial data.
• Fluency in English and strong SAS programming knowledge.
• Knowledge of regulatory requirements and CDISC SDTM/ADaM data standards.

Responsibilities

• Develop and document programs to produce datasets, listings, tables and figures.
• Validate programs and generate validation documentation.
• Ensure data preparation according to CDISC standards and SOPs.
• Collaborate with project team cross-functionally.
• Train group members on new processes and programs.

Skills

SAS programming

Analytical skills

Teamwork

Communication skills

English fluency

Education

BSc, MSc or equivalent in IT, mathematics, statistics or life sciences

Tools

CDISC SDTM/ADaM

SAS

Job description

Home/Office Based Either: Home or Office Based

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

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 validationHighly 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.