Senior Statistical Programmer Fsp

Cytel

7+ years

Not Disclosed

India Remote

10 Feb. 17, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Statistical Programmer FSP
Location: Hyderabad, Telangana, India
Job Type: Full-time
Posted: Feb. 12, 2025
Job ID: 438

Position Overview:

As a Senior Statistical Programmer, you will be working directly with a global pharmaceutical client, offering technical expertise and leading statistical programming activities across clinical trials. You will be expected to perform advanced SAS programming and be proficient in CDISC standards (SDTM & ADaM). This role can be fully remote, though the job is based in Hyderabad, Telangana.

Responsibilities:

Lead programmer and primary point of contact for clinical trial protocols.
Provide technical expertise for statistical programming, automated report development, and submission data standard packages.
Support large/complex drug/vaccine clinical development projects.
Perform data manipulation, analysis, and reporting of clinical trial data (ISS/ISE) using SAS programming.
Generate and validate SDTM and ADaM datasets, analysis files, tables, listings, and figures (TLFs).
Conduct production, QC/validation programming, and complex ad-hoc reports.
Apply a strong understanding of efficacy analysis.
Create and review submission documents and eCRTs.
Communicate with internal teams and clients regarding project specifications, status, issues, or inquiries.
Lead or mentor junior programmers, providing guidance to ensure results meet deadlines.
Adapt to changing priorities and execute projects effectively in a global team environment.

Qualifications:

Education: Bachelor’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related fields.
Experience:
- At least 7 years of SAS programming experience working with clinical trial data in the Pharmaceutical & Biotech industry (or 6+ years with a master’s degree).
- Experience leading studies, preferably managing multiple projects simultaneously.
- Strong SAS programming skills for data manipulation, analysis, and reporting.
- Experience implementing the latest CDISC SDTM/ADaM standards.
- Proficiency in R programming.
- Familiarity with drug development life cycles and clinical trial data reporting.
- Experience with define.xml, reviewer’s guides, and other submission documents.
- Knowledge of immunology, respiratory, or oncology studies would be a plus.
- Excellent analytical, troubleshooting, and problem-solving skills.
- Ability to deliver high-quality output under challenging timelines.

Additional Information:

Location: Hyderabad, Telangana, India (with potential for remote work).
Cytel is committed to professional development, innovative solutions, and contributing to advancements in clinical development.

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Senior Statistical Programmer Fsp

Job Description

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