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    Senior Statistical Programmer

    Sun Pharma
    4+ years
    Not Disclosed
    Princeton Junction
    10 Nov. 28, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

    Position: Senior Statistical Programmer
    Location: Princeton, NJ
    Company: Sun Pharmaceutical Industries Ltd. (Sun Pharma)

    About Sun Pharma

    Sun Pharmaceutical Industries Ltd. is the fourth-largest specialty generic pharmaceutical company in the world, with revenues exceeding $5 billion USD. With more than 40 manufacturing facilities, Sun Pharma provides high-quality, affordable medicines trusted by healthcare professionals and patients in over 100 countries worldwide, including the United States. The company’s philosophy, Sunology, reflects values such as Humility, Integrity, Passion, and Innovation, which guide their commitment to stakeholders—patients, physicians, and employees.

    Position Overview

    Sun Pharma is seeking a Senior Statistical Programmer within its Clinical Development organization. The position is based in Princeton, NJ. The Senior Statistical Programmer will lead the programming activities for one or more Phase I-IV clinical studies, ensuring the timely and high-quality delivery of programming results in support of clinical studies, regulatory submissions, and ad hoc analyses. The role involves working closely with internal teams, external partners, and regulatory authorities to ensure compliance with industry standards.

    Key Responsibilities

    • Lead programming activities for one or more therapeutic areas or studies, ensuring timely and high-quality deliverables.
    • Develop and maintain programming documentation adhering to industry standards and best practices.
    • Create CDISC standard SDTM and ADaM mapping specifications, and oversee the development of SAS programs to generate datasets and reports (Tables, Listings, Figures).
    • Contribute to the creation and maintenance of standard and utility macros and participate in establishing statistical programming standards.
    • Engage in CRF annotation, review SAP, and help develop and review TLF specifications.
    • Handle P21-related items for regulatory submissions, including define.XML, aCRF, and other key regulatory documents for agencies such as FDA, EMA, and PMDA.
    • Support global regulatory submissions according to industry guidelines (sdTCG, DSC, eCTD), addressing any health authority requests.
    • Mentor and coach junior programmers, fostering a collaborative team environment.
    • Work independently and as part of a global team, managing deliverables and timelines with study leads and management.

    Qualifications

    Required

    • Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related discipline.
    • 4+ years of programming experience in clinical trial data processing within the biotechnology, pharmaceutical, or CRO industries.
    • Strong SAS programming skills in a clinical data environment.
    • Ability to work independently and as part of global interdisciplinary teams.
    • Good organizational, communication, and interpersonal skills.

    Preferred

    • Knowledge of additional programming languages such as R or Python.
    • Strong understanding of pharmaceutical clinical development, statistical concepts, and regulatory submissions (NDA, ANDA, etc.).
    • Extensive knowledge of CDISC standards, regulatory guidelines, and TAUG.
    • Prior PTL experience and ability to adapt to a fast-paced environment.
    • SAS certification is a plus.

    Compensation & Benefits

    • Competitive salary based on experience and geographical location.
    • Annual Performance Bonus Plan participation.
    • Comprehensive benefits package including:
      • Medical, dental, and vision coverage.
      • Life insurance and disability insurance.
      • 401(k) savings plan.
      • Flexible spending accounts and employee assistance programs.
      • Paid vacation and sick time.

    Equal Employment Opportunity

    Sun Pharma provides equal employment opportunities to all current and prospective employees. No individual will be discriminated against based on race, religion, gender, disability, or other protected characteristics.

    How to Apply

    Interested candidates should apply directly to Sun Pharmaceutical Industries Ltd. for consideration.

    Sun Pharmaceuticals does not accept unsolicited resumes from third-party agencies or search firms.

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