Senior Statistical Programmer (India)

Cytel; Kolkata Metropolitan Area; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Cytel in India seeks a Sr. Statistical Programmer to support gene therapy development programs within its Biometrics team. You will design and code SAS programs for clinical trial data analysis and submission, generating SDTM and ADaM datasets and supporting CDISC submissions.

You will review define.xml, create reviewers guides for SDTM/ADaM, and maintain study documents per standard processes. MS in biostatistics with 5–8 years pharma experience, or BS with 7–10 years, plus strong SAS skills

Qualifications

• MS in biostatistics or related field; 5–8 years in pharma.
• BS in biostatistics or related field; 7–10 years in pharma.
• Advanced SAS skills including BASE SAS, SAS/STAT, SAS/GRAPH and Macro language.

Responsibilities

• Design and code SAS programs for assigned projects meeting objectives.
• Code complex SAS programs for analyses and CDISC submissions.
• Create specifications for derived datasets and analyze datasets, tables, figures, and listings.
• Perform QC checks of advanced SAS code for datasets and outputs.
• Review define.xml and create reviewers guide for SDTM/ADaM.
• Review and maintain study documents per standard process.
• Perform other duties as assigned.

Skills

SAS programming

SAS macro language

SAS/STAT

SAS/GRAPH

Strong communication

Education

MS in biostatistics or related field

BS in biostatistics or related field

Tools

CDISC knowledge

Job description

Sr. Statistical Programmer - FSP (India)

Join Cytel’s enthusiastic and collaborative Biometrics team by contributing to the overall success of our novel gene therapy development programs. The Sr. Statistical Programmer provides Statistical Programming technical support to team members.

Key Responsibilities

• Effectively designs and codes SAS programs for assigned project(s), consistently meeting objectives of the project
• Codes complex SAS programs for applications designed to analyze and report clinical trial data and for electronic submissions of data in CDlSC format with minimal instruction or input from the supervisor
• Create specifications for derived/analysis datasets Program analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS Generate SDTM domains, ADaM datasets
• Performs quality control checks of advanced SAS code for datasets and output produced by other Statistical Programmers
• Performs review on define.xml and creates reviewers guide for SDTM and ADaM datasets
• Review, and maintain study documents per the standard process
• Perform other duties as assigned

Technical And Communication Skills

• Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH
• Demonstrates intermediate knowledge of electronic submissions and CDlSC
• Proven technical proficiency in supporting daily operations and ensuring that project tasks are completed accurately and on schedule
• Effective communicator (written and verbal), especially within their area(s) of expertise

Preferred Education And Experience

• MS in biostatistics or a related field, with 5-8 years of experience in the pharmaceutical industry, or BS in biostatistics or a related field, with 7-10 years of experience in the pharmaceutical industry

Cytel Inc. is an Equal Employment /affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

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