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    Senior Associate, Principal Statistical Data Scientist

    Pfizer
    5-6 years
    Not Disclosed
    Chapel Hills Chennai
    10 July 18, 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, 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

    Job Description

    Position: Statistical Programmer

    Location: Flexible Type: Individual Contributor Role

    Primary Responsibilities:

    Programming and Deliverables:

    • Engage in productive hands-on programming to support deliverables in study/project/portfolio/standards teams with medium to high complexity statistical programming tasks.
    • Perform tasks independently with mentorship or advice from Programming Leads within the organization.
    • Act as co-lead/lead on selected projects/initiatives/activities and study deliverables as needed.
    • Guide, mentor, and monitor programmers within the team, collaborating with SDSLs on timelines, resource management, and quality deliverables.
    • Handle standards/study programming activities independently, collaborating across stakeholders in various time zones.
    • Ensure adherence to high-quality programming standards in daily work.
    • Ensure tasks are completed on time with quality and compliance to Pfizer processes with needed guidance.
    • Work collaboratively with study teams and stakeholders, such as clinicians and statisticians, on milestones and deliverables.
    • Engage in active self-learning and deliver solutions in statistical programming and data standards.
    • Contribute to SDSA initiatives globally and locally.
    • Be accountable for multiple projects/ongoing work activities (timelines, work plans, deliverables) of moderate complexity within a work team.
    • Support standards/study deliverables and assist SDSLs with team assignments.

    Technical Tasks:

    • Review, develop, validate, and review datasets, TFL as per CDISC-aligned Pfizer Standards or Pfizer Data Standards for study/project/portfolio.
    • Contribute up to 80% of time to programming deliverables in SAS, R, or Python, and 20% to self-learning, development, and growth.
    • Explore the existing code base, execute/perform runs as required, and develop/modify code as per needs and specifications.
    • Ensure appropriate documentation and QC across the lifespan of the study for all programming deliverables across standards, programming, and submissions.
    • Understand and implement standard/study/project/portfolio requirements and specifications, working with global stakeholders to ensure completion of goals and milestones.

    Knowledge and Skills:

    • Knowledgeable in core safety standards and TA standards pertinent to their project.
    • Lead the development of standards necessary for their study.
    • Exhibit routine and occasionally complex problem-solving skills, seeking direction when appropriate.
    • Regularly update leads on progress and time estimations to ensure smooth operations and accurate planning.
    • Support in accomplishing department and organization mission by completing assigned tasks.
    • Act as mentor to junior team members.
    • Advance job knowledge by participating in opportunities both globally and locally.

    Qualifications / Skills:

    Education:

    • Bachelor’s or Master’s Degree (preferred) in Statistics, Computer Sciences, Engineering, Pharmacy, Biological Sciences, IT, or related field.

    Experience:

    • At least 5-6 years of relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.
    • Understanding of clinical data and drug development process, CDISC standards required.
    • Hands-on experience in statistical programming and SAS.
    • Expertise in clinical trials with an understanding of data operations required for reporting clinical data.

    Knowledge and Abilities:

    • Good understanding of ICH and regulatory guidelines.
    • Working knowledge of clinical data and relevant data standards.
    • Ability to work with stakeholders across time zones under tight timelines.
    • Strong written and oral communication skills.
    • Strong time and project management skills.
    • Strong competencies and interests in innovation and problem-solving.
    • Proven ability to operate with limited oversight.
    • Knowledge of at least one therapeutic area.

    Work Location Assignment:

    • Flexible

    Equal Opportunity Employer:

    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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