Senior Statistician

OPIS; Batu Pahat; Remote; MYR 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Senior Statistician to join their remote team. This role involves leading statistical activities for clinical studies, mentoring junior staff, and collaborating with cross-functional teams. The ideal candidate will have a degree in Statistics and at least three years of experience in clinical research. You'll be responsible for designing studies, performing statistical analyses, and ensuring compliance with regulatory guidelines. Join a dynamic company that values innovation and offers opportunities for professional growth and development in a supportive environment.

Benefits

Competitive Salary

Bonuses

Professional Development Opportunities

Qualifications

• 3+ years experience in CRO, biotech, or pharma.
• Proven expertise in statistics for clinical research.

Responsibilities

• Responsible for statistical activities in clinical studies.
• Develop SAS programs for analysis datasets and reporting.

Skills

Statistical Analysis

SAS Programming

Clinical Research

Communication Skills

Project Management

Education

Degree in Statistics

Tools

SAS

CDISC Standards

Job description

Due to our ongoing global expansion, we have a great opportunity for a Senior Statistician to join our growing team, on a fully remote basis.

The Senior Statistician reports to the Biostatistics Coordinator, serves as the primary point of contact for statistical matters within the study team, liaises with external stakeholders, and ensures clinical data are analyzed in compliance with applicable standards, regulatory guidelines, and OPIS SOPs. The Senior Statistician provides advice on statistical methodology and study design to the study team and Sponsor, and acts as a mentor for junior staff.

This is a remote (work from home) position.

What you'll do:

1. Be responsible for all statistical activities related to assigned clinical studies, including study design, sample size estimation, analysis plan, analysis populations, statistical analyses, and reporting.
2. Work independently with minimal support from the Head of Biostatistics Unit; contribute to the design of clinical studies by providing appropriate statistical methodology.
3. Review study objectives and endpoints with the study team and/or Sponsor, and write detailed statistical analysis plans (SAP).
4. Generate randomization lists or procedures and collaborate with the Data Manager to produce related documentation.
5. Collaborate with the Data Management team to review the study CRF, define protocol deviations, edit checks, and other data quality controls.
6. Develop SAS programs and/or collaborate with SAS programmers to generate analysis datasets, mock shells, TFLs for reporting and publications.
7. Perform quality control of deliverables generated by other statisticians or SAS programmers.
8. Write the Statistical Report and/or the statistical sections of the Clinical Study Report.
9. Track activities and milestones to ensure timely project deliverables.
10. Liaise with Sponsor and external stakeholders regarding statistical activities and results.
11. Present and share knowledge at team meetings.
12. Assist in establishing and maintaining SOPs related to Biostatistics.
13. Organize and perform training for project teams and mentor junior staff.

What we are looking for:

1. Degree in Statistics (or equivalent) with specialization in medical or epidemiological statistics.
2. At least 3 years of experience in CRO, biotech, pharma, research institutes, or similar.
3. Proven knowledge and expertise in statistics and its applications to clinical research.
4. Solid knowledge and experience in drug development processes and GCP guidelines.
5. Proficiency in SAS and other statistical software packages.
6. Experience in developing CDISC standard specifications and datasets (SDTM, ADaM).
7. Knowledge of clinical trial systems (EDC, IVRS, IWRDS, EPRO, CTMS, etc.).
8. Excellent communication and teamwork skills.
9. Strong commitment to quality.
10. Proactive, organized, and independent in managing activities.
11. Flexible, innovative, and fluent in English.
12. Strong planning, organizational, and communication skills.
13. Team-oriented attitude.

What we offer:

We offer a competitive salary, bonuses, and other benefits, along with the opportunity to develop your professional career within an expanding international company.

Please review the information notice on the processing of personal data available on our company website.

Who we are:

OPIS is an international CRO with 25 years of experience conducting Phase I-IV, non-interventional, and medical device studies worldwide. We provide state-of-the-art technology solutions and innovative approaches to meet the increasing complexity of projects.

Our expertise spans all phases of drug-related trials, supporting Sponsors beyond therapeutic areas, including medical and diagnostic device investigations. With global clinical research locations, OPIS offers comprehensive services such as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture, quality assurance, and training.

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