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Parexel · 4 months ago

Statistical Programmer II (Clinical SAS Programmer), South Africa

United States

Full-time

Remote

Entry, Mid Level

1+ years exp

Parexel is committed to improving the world's health through clinical trials and regulatory consulting. The Statistical Programmer II role involves providing technical expertise in clinical trials, supporting programming activities related to clinical study data analysis and reporting, and may serve as a lead on smaller projects.

Pharmaceuticals

H1B Sponsor Likely

Responsibilities

Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation

Deliver best value and high quality service

Check own work in an ongoing way to ensure first-time quality

Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings

Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation

Maintain and expand local and international regulatory knowledge within the clinical industry

Develop knowledge of SAS and processes/procedures within other Parexel functional areas

Provide relevant training and mentorship to staff and project teams as appropriate

Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance

Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required

Proactively participate in process/quality improvement initiatives

Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions)

Qualification

SAS ProgrammingClinical Trial KnowledgeRegulatory ComplianceAnalytical SkillsAttention to DetailEffective CommunicationTime ManagementTeam CollaborationProblem Solving

Required

Excellent analytical skills

Proficiency in SAS with solid knowledge and understanding of the programming and reporting process. A minimum of 1.5 years Clinical (SAS) Programming experience is required

Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11

Ability to learn new systems and function in an evolving technical environment

Ability to manage competing priorities and flexibility to change

Attention to detail

Ability to successfully work as part of a global team

Work effectively in a quality-focused environment

Effective time management in order to meet daily metrics or team objectives

Show commitment to and perform consistently high-quality work

Business/operational skills that include customer focus, commitment to quality management, and problem solving

Competent in written and oral English

Good communication skills

Educated to degree level in a relevant discipline and/or equivalent work experience

Company

Parexel

Glassdoor3.9

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster.

Founded in 1983

Raleigh, North Carolina, US

10001+ employees

http://www.parexel.com

H1B Sponsorship

Parexel has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (33)

2024 (46)

2023 (41)

2022 (51)

2021 (54)

2020 (33)