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Manager, Statistical Data Sciences Lead

8-15 years
Not Disclosed
10 Dec. 6, 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

Role Summary
Pfizer is seeking a highly skilled Statistical Programming Lead to drive excellence in statistical programming deliverables for clinical trial data analysis. This role ensures the timely delivery of high-quality datasets, tables, listings, and figures while adhering to Pfizer SOPs and regulatory guidelines. The ideal candidate will bring technical expertise, leadership, and a commitment to advancing the research and development of Pfizer’s portfolio.

Key Responsibilities

  • Programming Leadership: Serve as the programming point of contact for study-level deliverables and support asset or submission-level tasks. Provide leadership for complex statistical programming deliverables and architecture development.
  • Delivery Management: Manage mid-to-small-sized projects or teams, ensuring adherence to timelines, quality standards, and compliance with Pfizer processes.
  • Team Guidance: Mentor and monitor programmers, collaborating with Senior Statistical Data Standards Leaders (SDSLs) on resource management and deliverables.
  • Stakeholder Collaboration: Work with multidisciplinary teams, including clinicians and statisticians, to meet milestones and deliverables effectively.
  • Quality Assurance: Maintain high-quality programming standards and ensure adherence to regulatory guidelines and internal SOPs.
  • Innovation and Initiatives: Actively engage in self-learning, contribute to Statistical Data Standards and Analysis (SDSA) initiatives, and deliver innovative solutions in statistical programming.
  • Standards Development: Lead the architecture development of standards for major phases of delivery while supporting global and local SDSA activities.

Qualifications and Skills

  • Education: Bachelor’s or Master’s degree (preferred) in Statistics, Biological Sciences, IT, or related fields.
  • Experience: 8–15 years of relevant experience in pharmaceutical, biotech, CRO, or regulatory agencies.
  • Technical Expertise: Proficient in statistical programming, SAS, and clinical trial data operations. Familiarity with CDISC standards is highly desirable.
  • Regulatory Knowledge: Strong understanding of ICH and regulatory guidelines and statistical methodologies.
  • Project Management: Proven ability to manage projects, lead small teams, and deliver quality outcomes on time.
  • Communication Skills: Exceptional written and verbal communication, with the ability to present complex technical information to non-technical audiences.
  • Global Collaboration: Experience working across international boundaries and managing remote teams.
  • Problem Solving: Expertise in solving routine and complex problems using experience-based strategies.

Work Location Assignment: Global Remote

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