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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)

    Company Overview

    Sun Pharmaceutical Industries Ltd. is the fourth-largest specialty generic pharmaceutical company globally, with over $5 billion in revenues. 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. Sunology, the company's unique ideology, is centered around Humility, Integrity, Passion, and Innovation, reflecting Sun Pharma's commitment to its stakeholders, including patients, healthcare providers, and employees.

    Position Overview

    The Senior Statistical Programmer will be responsible for leading statistical programming activities across multiple studies and therapeutic areas. This includes developing SAS programs for clinical data processing, adhering to CDISC standards, and ensuring regulatory compliance for submissions to global health authorities. The individual will contribute to the development of programming standards, mentoring junior team members, and maintaining high-quality deliverables for regulatory submissions.

    Key Responsibilities

    Leadership & Programming

    • Lead statistical programming activities for Phase I-IV studies in various therapeutic areas, ensuring high-quality programming deliverables and timely completion.
    • Develop and maintain programming documentation following established standards and processes.
    • Create CDISC standard SDTM and ADaM mapping specifications and SAS programs for dataset creation, along with generating reports (Tables, Listings, and Figures).
    • Oversee the development of standard macros and utility functions, ensuring alignment with regulatory standards.
    • Participate in CRF annotation, SAP review, and TLF specifications development.
    • Handle all P21-related items, including aCRF, define.XML, cSDRG, ADRG, and ARM for FDA/EMA/PMDA regulatory submissions.
    • Support regulatory submissions, ensuring compliance with global health authority guidelines (e.g., sdTCG, DSC, eCTD).
    • Mentor and coach junior programmers, providing guidance and sharing expertise on clinical programming best practices.

    Collaboration & Support

    • Work closely with internal teams and external functional service providers to ensure timely delivery of programming results.
    • Collaborate on regulatory submission tasks, addressing any health authority requests related to clinical data.
    • Demonstrate company values of excellence, competence, collaboration, innovation, respect, and accountability in all work.

    Qualifications

    Required Qualifications

    • Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or a related field.
    • 4+ years of programming experience in the biotechnology, pharmaceutical, or CRO industries, with a focus on clinical trial data.
    • Strong SAS programming skills, with expertise in clinical data environments.
    • Ability to work independently and collaborate with interdisciplinary, global teams.

    Preferred Qualifications

    • Knowledge of R, Python, or other programming languages is a plus.
    • Solid understanding of statistical concepts, clinical trial principles, and regulatory submissions (NDA, ANDA, etc.).
    • Extensive knowledge of CDISC standards, Regulatory guidance, and TAUG.
    • Prior PTL experience is beneficial, with strong attention to detail and ability to adapt to fast-paced environments.
    • SAS certification is a plus.

    Compensation & Benefits

    • Base compensation will be determined based on geographical location and experience.
    • Participation in the Annual Performance Bonus Plan and Long-Term Incentive Plan.
    • Comprehensive benefits package, including medical, dental, and vision coverage, life insurance, disability insurance, and 401(k) plan.
    • Paid time off, including vacation time and sick time.
    • Access to employee assistance programs.

    Equal Employment Opportunity

    Sun Pharmaceutical is an equal opportunity employer and does not discriminate based on race, religion, gender, disability, sexual orientation, military status, or any other protected category.

    How to Apply

    Interested candidates should submit their applications directly to Sun Pharmaceutical Industries Ltd.

    Note: Sun Pharmaceuticals is not accepting unsolicited resumes from agencies or search firms for this job posting.

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    Warsaw |

    Remote :

    Belgium | Bishop | Remote - Middle East | McFarland | Riga | Xzagreb | Minnesota | Tulsa | Remote - Europe | Remote - South America (Latin Americal) | Medan | Springville | Remote - Africa | Bountiful | Hammond | Thailand | Texas | Zaragoza | Slovakia | French | Nairobi | Lousiana | Lenexa | Remote, USA | Manipal | Green Way | Blue Bell | Victoria | Ireland | Leinster | Remote | Castlebar | Faridabad | Switzerland | Melbourne | Hungary |

    Bucharest :

    Bucharest |

    Makkah :

    Rabigh | Khulais | Riyadh | King Abdullah Economic City | Jeddah | Najran |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand | South Africa |

    Brazil :

    Sao paulo | Brazil |

    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |