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    Manager, Statistical Data Sciences Lead

    Pfizer
    8+ years
    Not Disclosed
    Mumbai
    10 Nov. 13, 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, 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

    Qualifications / Skills:

    • Bachelor or Master’s degree (preferred) in Statistics, Biological Sciences, IT, or a related field.
    • At least 8-15 years of relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency setting.
    • Hands-on experience with Statistical Programming and SAS.
    • Expertise in clinical trials with a solid understanding of data operations for reporting clinical trial data.
    • Strong knowledge of ICH and Regulatory Guidelines.
    • Excellent problem-solving skills with the ability to solve complex issues using experience and extrapolation to new situations.
    • Comprehensive understanding of clinical data and relevant data standards.
    • Extensive knowledge of routine statistical methodologies and their application to programming.
    • Familiarity with vendor processes.
    • Proven experience in developing successful partnerships within study teams.
    • Strong written and oral communication skills, as well as project management capabilities.
    • Ability to present technical information to non-technical audiences.
    • Ability to operate independently.
    • Exposure to working across international boundaries and cultures.
    • Ability to manage customer expectations.
    • Experience managing work in remote or global settings.
    • CDISC experience is highly desirable.

    Responsibilities:

    • Serve as an individual contributor, project/application manager, or people manager of small teams.
    • Lead programming efforts ensuring excellence in delivering analysis-ready datasets, tables, listings, and figures to support the research, development, and commercialization of Pfizer’s portfolio, following Pfizer SOPs and processes.
    • Act as the programming point of contact at the study level, providing support at the asset/submission level (TA and Study), handling complex statistical programming deliverables for study teams.
    • Lead the development of architecture and standards for major phases of delivery.
    • Manage mid and small-sized projects and/or small teams.
    • Co-lead or lead selected projects, initiatives, and study deliverables.
    • Guide, mentor, and monitor programmers within the team while collaborating with Senior SDSLs on timelines, resource management, and quality deliverables.
    • Independently manage standards and study programming activities, collaborating with stakeholders across different time zones.
    • Ensure adherence to high-quality programming standards and compliance with Pfizer’s processes.
    • Collaborate with study teams and stakeholders, such as clinicians and statisticians, on milestones and deliverables.
    • Actively engage in self-learning and deliver solutions in statistical programming and data standards.
    • Contribute to SDSA initiatives globally and locally.

    Pfizer Equal Opportunity Employer Statement:

    Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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