Biostatistician II

Job Description

Job Description:

We are seeking a detail-oriented and experienced Biostatistician II to support statistical analyses for clinical research studies. This role involves developing and validating SAS programs, preparing statistical documentation, and ensuring compliance with regulatory standards such as CDISC. The ideal candidate will have a strong foundation in statistics, clinical trial methodology, and statistical programming.

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Key Responsibilities:

• Develop, validate, and maintain SAS programs to generate analysis datasets, tables, listings, and figures (TLFs) as per statistical analysis plans.
• Design and verify randomization codes to ensure clinical trial integrity.
• Prepare statistical sections of protocols, including sample size calculations and annotated shell data displays.
• Provide specifications for the structure, content, and algorithms of status and analysis datasets.
• Perform and oversee quality control (QC) of data displays and datasets to ensure accuracy and compliance with CDISC standards (SDTM, ADaM).
• Conduct independent validation of datasets created by other programmers or statisticians.
• Maintain project documentation including protocols, annotated CRFs, SAPs, and programming/QC records.
• Organize and manage electronic project directories to ensure accessibility and version control.
• Mentor junior programmers and provide training on SAS programming and clinical data standards.

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Primary Skills:

• Statistical Programming: Proficiency in SAS for clinical data analysis
• Clinical Research: Understanding of clinical trial design, randomization, and statistical methodology
• Data Standards: Familiarity with CDISC, SDTM, and ADaM
• Quality Assurance: Experience in QC processes and dataset validation
• Documentation: Ability to create and maintain technical and regulatory documentation

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Secondary Skills:

1. Statistical Analysis:
   • Sample size estimation, inferential statistics, protocol development
2. Data Management:
   • Annotated CRFs, dataset specifications, metadata handling
3. Communication:
   • Clear documentation and collaboration with cross-functional teams
4. Mentorship:
   • Training and guiding junior staff in programming and standards
5. Project Organization:
   • File management, version control, and audit readiness

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Preferred Qualifications:

1. Master’s degree in Statistics or related field (or Bachelor’s with equivalent experience)
2. Minimum 3 years of experience as a Biostatistician in the clinical research industry
3. Proficiency in SAS and clinical data analysis software
4. Experience with CDISC standards and regulatory compliance
5. Prior experience in mentoring or training junior team members

Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications. 1. Applies scientific methods to analyse and solve software engineering problems. 2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance. 3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers. 4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities. 5. The software engineer collaborates and acts as team player with other software engineers and stakeholders.