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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Manager, Statistical Data Sciences Lead

Job Description

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