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    Senior Statistical Programmer

    Cytel
    5-12 years
    Not Disclosed
    Remote
    10 June 28, 2024
    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, 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

    Company Overview: Cytel Software Corporation

    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.

    Job Title: Sr. Statistical Programmer - FSP (India)

    Key Responsibilities:

    • Programming and Analysis:

      • Effectively design and code SAS programs for assigned projects, consistently meeting project objectives.
      • Code complex SAS programs for applications designed to analyze and report clinical trial data and for electronic submissions of data in CDISC 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 and ADaM datasets.

    • Quality Control:

      • Perform quality control checks of advanced SAS code for datasets and output produced by other statistical programmers.
      • Perform reviews on define.xml and create reviewers guide for SDTM and ADaM datasets.
      • Review and maintain study documents per the standard process.

    • Other Duties:

      • 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 CDISC.
    • 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.

    Additional Information:

    • 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.
    • Cytel does not accept referrals from employment businesses and/or employment agencies for the vacancies posted on this site.
    • All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel.
    • The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/agency and Cytel.
    • In the absence of such written authorization, any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall, therefore, not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.

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