Role overview

Qualifications

Educated to degree level in a relevant discipline and/or equivalent work experience
Proficiency in SAS
Knowledge of SOPs/Guidelines, ICH-GCP, and applicable regulations

Responsibilities

Assist in the coordination of project start-up activities and tracking documentation
Deliver high-quality statistical programming for assigned projects
Maintain and expand regulatory knowledge and provide training to staff
Ensure compliance with SOPs/Guidelines and participate in audits

Key facts

Remote from: Taiwan
Full time
Mid-level (2-5 years)
English

Hard skills

Base SAS Project Management Regulatory Compliance Process Improvement Customer Centricity

Other skills

Quality Control
Physical Flexibility
Mentorship
Analytical Skills
Detail Oriented
Teamwork
Time Management
Problem Solving
Communication

About the company

Parexel

Pharmaceuticals

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. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

Company details

Company typeXLarge

IndustryPharmaceuticals

Company size10001

Links

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Job description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Accountabilities:

Project Management

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

Statistical Programming for Assigned Projects

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.

Training

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.

General

Maintain all supporting documentation for studies in accordance
with SOPs/Guidelines to ensure traceability and regulator 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).

Skills:

Excellent analytical skills.
Proficiency in SAS.
Knowledge and understanding of the programming and reporting process.
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.

Knowledge and Experience:

Competent in written and oral English.
Good communication skills.

Education:

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