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Senior Statistical Programmer Fsp

7+ years
Not Disclosed
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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