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    Manager Statistical Programming

    Sun Pharma
    8+ 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: Manager, Statistical Programming
    Location: Princeton, NJ
    Company: Sun Pharmaceutical Industries Inc. (Sun Pharma)

    About Sun Pharma

    Sun Pharmaceutical Industries Inc. (Sun Pharma) is the fourth-largest specialty generic pharmaceutical company globally, with revenues exceeding $5 billion USD. With more than 40 manufacturing facilities, the company delivers high-quality, affordable medicines to healthcare professionals and patients in over 100 countries worldwide, including the United States. The company embodies Sunology, a combination of Humility, Integrity, Passion, and Innovation, reflecting its promise to patients, physicians, and employees.

    Position Overview

    Sun Pharma is seeking a Manager, Statistical Programming to join its Clinical Development organization in Princeton, NJ. The Manager will provide comprehensive programming expertise and leadership across multiple clinical studies. This position involves managing and overseeing all statistical programming activities while ensuring that programming deliverables are of high quality and completed on time, supporting clinical studies, regulatory submissions, and ad hoc analyses. The role will require close collaboration with internal and external stakeholders and participation in department initiatives, including the development of programming standards and training materials.

    Key Responsibilities

    • Lead statistical programming activities across therapeutic areas and clinical studies, ensuring timely and quality deliverables.
    • Develop and maintain programming documentation in alignment with company standards and processes, including CDISC SDTM and ADaM specifications.
    • Oversee the creation of SDTM and ADaM datasets, following CDISC standards, and generate associated reports (Tables, Listings, Figures).
    • Contribute to the development of standard macros, programming SOPs, and statistical programming guidelines.
    • Participate in CRF annotation, review SAP, and contribute to the development and review of TLF specifications.
    • Handle P21-related regulatory submission items, including define.XML, aCRF, and cSDRG for agencies such as FDA, EMA, and PMDA.
    • Support global regulatory submissions and collaborate with relevant functions to address regulatory authority requests (e.g., sdTCG, DSC, eCTD).
    • Contribute to department goals, training guidelines, and serve as a subject matter expert (SME) in statistical programming.
    • Mentor and coach junior programmers, fostering a collaborative, high-performance team environment.
    • Manage the planning and execution of programming deliverables with the study team and project management.

    Qualifications

    Required

    • Bachelor’s degree in Statistics, Computer Science, Mathematics, Engineering, Life Science, or a related discipline.
    • 8+ years of programming experience in clinical trial data processing within the biotechnology, pharmaceutical, CRO, or healthcare industries.
    • Proficiency in SAS programming in a clinical data environment.
    • Excellent organizational, interpersonal, and communication skills.
    • Ability to work independently and as part of interdisciplinary global teams.
    • A positive attitude, strong problem-solving skills, and a growth mindset.

    Preferred

    • Working knowledge of R or Python.
    • Deep understanding of pharmaceutical clinical development, statistical concepts, and regulatory submissions (e.g., NDA, ANDA).
    • Expertise in CDISC standards and regulatory guidance (e.g., TAUG).
    • Demonstrated hands-on programming skills and experience with people management.
    • SAS certification is a plus.

    Compensation & Benefits

    • Competitive salary, adjusted 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 is an equal opportunity employer and ensures that all individuals are treated fairly and without discrimination. The company does not discriminate on the basis of race, religion, sex, disability, or any other protected characteristic.

    How to Apply

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

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

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