Senior Statistical Programmer

Cytel; India; Remote; INR 1,000,000 - 1,500,000; Full time

Job summary

A leading biotechnology company is seeking a Senior Statistical Programmer in India. This remote role involves leveraging advanced SAS programming skills and CDISC standards to support clinical trials. Ideal candidates will have at least 7 years of experience in SAS programming, robust data manipulation capabilities, and a strong understanding of Efficacy analysis.

Qualifications

• At least 7 years of SAS programming experience with clinical trial data.
• Strong SAS data manipulation, analysis, and reporting skills.
• Familiarity with drug development life cycle.

Responsibilities

• Perform data manipulation, analysis, and reporting of clinical trial data.
• Generate and validate SDTM and ADaM datasets and analytical files.
• Communicate with internal cross-functional teams and clients.

Skills

SAS programming

CDISC standards

Data manipulation and analysis

Efficacy analysis

Analytical skills

Troubleshooting skills

Education

Bachelor’s degree in Statistics, Computer Science, Mathematics

Tools

SAS

Job description

Overview

As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote.

Responsibilities

• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
• Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs)
• Production and QC / validation programming
• Generating complex ad-hoc reports utilizing raw data
• Applying strong understanding/experience of Efficacy analysis
• Creating and reviewing submission documents and eCRTs
• Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
• Performing lead duties when called upon
• Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
• Being adaptable and flexible when priorities change

Qualifications

• Bachelor’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
• At least 7 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 5 years of related experience with a master’s degree or above.
• Study lead experience, preferably juggling multiple projects simultaneously preferred.
• Strong SAS data manipulation, analysis and reporting skills.
• Solid experience implementing the latest CDISC SDTM / ADaM standards.
• Proficiency in Efficacy analysis.
• Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
• Submissions experience utilizing define.xml and other submission documents.
• Experience supporting immunology, respiratory or oncology studies would be a plus.
• Excellent analytical & troubleshooting skills.
• Ability to provide quality output and deliverables, in adherence with challenging timelines.
• Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Information Technology, Research, and Health Care Provider

Industries

• Biotechnology Research
• Hospitals and Health Care
• Medical Equipment Manufacturing

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