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    Senior Team Member - Coe Statistician

    Cipla
    3+ years
    Not Disclosed
    Goa
    10 Feb. 7, 2025
    Job Description
    Job Type: Full Time Education: M.Sc/PhD 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

    Senior Team Member – COE Statistician

    Posting Date: February 5, 2025
    Country: India
    State: Goa
    Location: Bangalore/Goa/Vikhroli
    Req ID: 91531

    Division: Quality

    Department: Corporate Quality Assurance

    Sub-Department: Quality Compliance and Sustainability

    Employment Type: [Specify]

    Job Purpose

    The Senior Statistician will act as a Subject Matter Expert (SME) responsible for managing junior statisticians, reviewing statistical justification reports, and ensuring regulatory compliance. The role involves statistical assessment for manufacturing, product development, and quality data across Cipla’s global sites. Additionally, this position requires interaction with cross-functional teams to apply statistical methodologies for trend evaluations, justifications, and assessments. The role may also involve advanced tools such as Analytics, AI, and Machine Learning to meet business requirements.

    Key Responsibilities

    1. Global Statistical Support

    • Provide statistical support through the preparation, review, and approval of statistical reports for all Cipla global manufacturing sites.

    2. Life Cycle Management & Product Quality Review (APQR)

    • Offer statistical inputs for Annual Product Quality Reviews (APQR) when process parameters show low/inadequate performance across sites.
    • Assist APQR personnel in preparing statistical analyses, graphs, and trends for reports.

    3. Implementation of New Statistical Concepts

    • Implement new statistical methodologies to overcome deviations during validation batches.
    • Support Root Cause Analysis (RCA) for deviations, OOT (Out of Trend), and OOS (Out of Specification) reports.

    4. Limit Establishment & Process Monitoring

    • Define Alert Limits, Frequency Limits, and Trend Limits for Critical Process Parameters (CPP) and Environmental Monitoring Data across Cipla sites.
    • Conduct training sessions on pharmaceutical statistics, process monitoring, and shelf-life analysis for APQR, CPV, and validation teams.

    5. Design of Experiments (DOE) & Equipment Qualification

    • Mentor junior statisticians and optimize methodologies using AI, ML, and advanced analytics tools.
    • Oversee DOE implementation for equipment/machine qualification.
    • Manage Minitab software licenses and renewals within the function.

    6. Innovation & Process Excellence

    • Identify and integrate new statistical methodologies to enhance business outcomes.
    • Ensure compliance with regulatory requirements for statistical justifications in investigations (OOS/OOT/Deviations).
    • Standardize statistical procedures across multiple sites despite variations in facilities, dosage forms, and customer requirements.

    Key Interactions

    • Corporate Quality Assurance, Integrated Product Development, Regulatory Affairs, Development Quality Assurance, Technology Transfer, and Manufacturing.
    • All Cipla manufacturing sites, including Site Manufacturing, Quality Assurance, Quality Control, and Manufacturing Science & Technology (MS&T) groups across different geographies.

    Key Dimensions & Decision-Making

    • Oversee a team of 2-3 statisticians supporting 20+ global Oral Formulation sites, handling 200-500 statistical assessments annually.
    • Provide insights into data to facilitate corporate and site-level decision-making.
    • Influence batch performance, unit performance, test method performance, and resolution of investigations.
    • Guide method development for statistical analysis.

    Qualifications & Experience

    Education:

    • M.Sc. or Ph.D. in Statistics OR Master’s/Ph.D. in Engineering with Statistics specialization.

    Experience:

    • 6-9 years of experience applying statistical/data tools in the pharmaceutical industry, specifically in pharma manufacturing and product development.
    • Experience in leading a team of 2-3 statisticians is required.
    • Additional Advantage:
      • Experience in Data Science, Analytics, Power BI, MS SharePoint/Power Apps, Lean Six Sigma (Green/Black Belt), and PQS-Culture of Excellence.

    Skills & Competencies:

    • Strong communication and team management skills.
    • Expertise in data analysis, statistical applications, and troubleshooting in pharma manufacturing.
    • Proficiency in statistical software applications:
      • Mandatory: MINITAB
      • Preferred: JMP, MS Office, MS SharePoint, Power Automate, Power Apps, Power BI, Python/R, or other statistical tools.

    Job Location: Bangalore/Goa/Vikhroli

    Shift Hours: [Specify]

     

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    Lima |

    Cebu Province :

    Cebu City |

    Philippines :

    Manila |

    Mazovia :

    Warsaw |

    Remote :

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

    Bucharest :

    Bucharest |

    Makkah :

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

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand | South Africa |

    Brazil :

    Sao paulo | Brazil |

    South America :

    Peru | Argentina |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hà Nội | Hanoi |

    Ho Chi Minh :

    Ho Chi Minh City |