Senior Scientist, Statistical Programming

MSD Malaysia; North Wales (Montgomery County); On-site; USD 80,000 - 100,000; Full time

Job summary

MSD Malaysia is seeking a programming professional to support statistical programming activities for clinical trial data analysis. The role requires developing SAS programs to create and validate analysis datasets for Clinical Study Reports and regulatory submissions.

Applicants should have a Master’s degree and relevant experience in SAS programming for clinical trials, with a strong focus on ensuring timely and high-quality deliverables. This position is crucial for collaborating with biostatisticians and other stakeholders in the clinical development process.

Qualifications

• 3 years of experience in SAS programming in clinical trials.
• Experience developing analysis datasets for Phase 2 and 3 clinical trials.
• Ability to interpret and execute clinical trial statistical analysis plans.

Responsibilities

• Support statistical programming activities for clinical trial data analysis.
• Develop SAS programs to create and validate analysis datasets.
• Collaborate with biostatisticians and project leads to ensure timely deliverables.

Skills

SAS programming

Clinical trial data analysis

Statistical programming

CDISC standards

Education

Master’s degree in Computer Science, Statistics, or a related field

Bachelor's degree in Computer Science, Statistics, or a related field

Job description

Responsibilities

Support statistical programming activities for clinical trial data analysis. Develop SAS programs to create and validate analysis datasets (ADaM) and summaries (TFLs) in support of Clinical Study Reports and regulatory submissions (FDA, EMA, etc.). Collaborate with biostatisticians, project leads, and other stakeholders in ensuring project plans are executed efficiently with timely and high-quality deliverables. Develop effective study and report programming and validation utilizing global CDISC, ICH, and Therapeutic Areas standards and following departmental SOPs and good programming practices. Maintain and manage a project plan including resource forecasting. Coordinate activities of a global programming team. Participate in departmental strategic initiative teams.

Requirements

• Master’s degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biomedical Engineering, or a closely related field and 3 years of experience in the position offered or a related role; OR a Bachelor's degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biomedical Engineering, or a closely related field and 5 years of experience in the position offered or a related role.
• Must have 3 years of experience with all the following: Developing analysis and reporting deliverables for Phase 2 and 3 clinical trials, including creation of analysis datasets, tables, graphics, and listings, for planned and unplanned analyses.
• SAS programming in a clinical trial environment including data step and procedures, macros, graphics, ODS.
• Interpreting and executing on clinical trial statistical analysis plans.
• Utilizing CDISC standards to create ADaM and SDTM datasets.
• Designing and developing complex programming algorithms.
• Ensuring process compliance and deliverable quality.

Required Skills

• Preferred Skills:

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