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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Senior Associate, Principal Statistical Data Scientist

Job Description

Job Description

Position: Statistical Programmer

Primary Responsibilities:

Qualifications / Skills:

Work Location Assignment:

Equal Opportunity Employer:

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