Biostatistician I

Biostatistician I
Job Description:

We are seeking a skilled and detail-oriented Statistician to support statistical analyses for clinical research studies. This role involves designing and executing statistical components of protocols, generating randomization codes, and preparing annotated shell data displays. The Statistician will contribute to the development of statistical analysis plans and ensure the accuracy and compliance of data displays with regulatory standards.

Statisticians report to the Biostatistics Manager and collaborate closely with cross-functional teams in a clinical research environment.

Key Responsibilities:

• Conduct statistical analyses as outlined in statistical analysis plans, including generating statistical graphics and verifying randomization codes.
• Prepare statistical sections of clinical study protocols, including sample size calculations.
• Annotate shell data displays and provide specifications for the structure, content, and algorithms of status and analysis datasets.
• Perform and supervise quality control (QC) of data displays and inferential statistics.
• Design, plan, and execute biostatistical components of clinical studies using sound statistical methodology.
• Develop statistical analysis plans (SAPs) and reporting specifications.
• Review and validate tables, listings, and figures (TFLs), tabulation datasets, and derived datasets.
• Analyze and interpret results from clinical studies independently or under guidance.
• Maintain project documentation and contribute to cross-functional interactions.
• Utilize advanced computer skills for documentation and reporting using MS Word, Excel, PowerPoint, and project management tools.

Primary Skills:

• Statistical Analysis: Sample size estimation, inferential statistics, protocol development
• Programming: Proficiency in SAS and clinical data analysis software
• Data Standards: Familiarity with CDISC, SDTM, and ADaM
• Documentation: Annotated CRFs, SAPs, shell displays, and QC records
• Communication: Effective verbal and written communication in English

Secondary Skills:

1. Clinical Research:
   • Understanding of clinical trial methodology and regulatory requirements
2. Quality Assurance:
   • QC of datasets and statistical outputs
3. Collaboration:
   • Cross-functional teamwork and stakeholder engagement
4. Project Organization:
   • File management and audit readiness
5. Mentorship:
   • Support and guidance for junior team members

Preferred Qualifications:

1. Master's degree in Statistics or related field
2. Minimum 3 years of experience as a Statistician for Senior level; minimum 1 year or EDETEK training and supervisory approval for non-Senior level
3. Proficiency in SAS and similar clinical data analysis tools
4. Experience in preparing statistical components of protocols and SAPs
5. Strong analytical and organizational skill

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.

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