Senior Statistical Programmer at Parexel

, , Taiwan -

Full Time

Start Date

Immediate

Expiry Date

21 Mar, 26

Salary

0.0

Posted On

21 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical Skills, SAS, Programming, Reporting Process, Project Management, Organizational Skills, Attention to Detail, Quality Control, Communication Skills, Customer Focus, Problem Solving, Presentation Skills, Business Awareness, Regulatory Knowledge, Statistical Programming, Mentorship

Industry

Pharmaceutical Manufacturing

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 Ability to fill Statistical Programming Lead role on projects Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to. Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget. Monitor project resourcing, project budgets, and identify changes in scope. Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Review statistical analysis plans and mock-shells. Review database set-up specifications. Interact with sponsors and internal stakeholders with regard to statistical programming issues. Assist project teams in the resolution of problems encountered in the conduct of their daily work. 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/QC derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings. Produce/QC dataset specifications and other process supporting documents and submission documentation. Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements. 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. General 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 and/or lead process/quality improvement initiatives. Provide consultancy to internal and external sponsors with regard to statistical programming tasks. Represent Parexel at sponsor marketing and technical meetings. Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions). Skills: Excellent analytical skills. Proficiency in SAS. Extensive 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. Strong project management skills. Strong organizational skills, ability to manage competing priorities, and flexibility to change. Attention to detail. Ability to successfully lead 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. Demonstrate commitment to refine quality processes. Good presentation skills. Good business awareness/business development skills (including financial awareness). Knowledge and Experience: Competent in written and oral English. Excellent communication skills. Education: Educated to degree level in a relevant discipline and/or equivalent work experience. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

Responsibilities

The Senior Statistical Programmer will lead statistical programming efforts on projects, ensuring adherence to timelines and budgets while coordinating a programming team. They will also deliver high-quality statistical programming outputs and maintain compliance with regulatory standards.