Job Title: Statistical Programmer - Onsite
Location: Boston, MA
Job Summary:
We are seeking a highly skilled and detail-oriented Statistical Programmer to join our [company/organization] team. The Statistical Programmer will be responsible for programming, validating, and maintaining statistical databases and software tools. The ideal candidate will have a strong background in statistics, programming, and data management, with the ability to work collaboratively with cross-functional teams, including biostatisticians, data managers, and clinical researchers.
- Key Responsibilities:Statistical Programming:
- Develop and maintain statistical programs using SAS, R, or other relevant software to support clinical trials, epidemiological studies, or other research projects.
- Create and validate data sets, tables, listings, and graphs for clinical study reports, regulatory submissions, and publications.
- Generate and review analysis datasets (ADaM, SDTM) following regulatory standards (e.g., CDISC).
- Data Management:
- Collaborate with data management teams to ensure accurate data collection, cleaning, and preparation for analysis.
- Design and implement efficient data manipulation, transformation, and validation processes.
- Documentation and Reporting:
- Prepare detailed documentation of programming processes, datasets, and outputs in accordance with regulatory guidelines and company SOPs.
- Contribute to the creation and review of statistical analysis plans (SAP) and other study documentation.
- Collaboration and Communication:
- Work closely with biostatisticians to develop analysis specifications and ensure the accuracy and integrity of statistical outputs.
- Participate in project meetings, providing updates on programming activities and timelines.
- Collaborate with clinical and regulatory teams to support data submissions to regulatory authorities.
- Quality Control:
- Conduct quality checks and peer reviews of programs and datasets to ensure compliance with industry standards and regulatory requirements.
- Implement best practices in statistical programming, including version control, testing, and validation.
- Qualifications:Education:
- Bachelor’s degree or higher in Statistics, Biostatistics, Computer Science, Mathematics, or a related field.
- Experience:
- Minimum of 6 years of experience in statistical programming, preferably in a pharmaceutical, biotechnology, or healthcare setting.
- Proven experience with SAS, R, or other statistical programming languages.
- Experience with clinical trial data and familiarity with regulatory submission requirements (e.g., FDA, EMA).
- Skills:
- Strong programming skills with proficiency in SAS, R, and other relevant tools.
- In-depth knowledge of statistical methodologies and data analysis techniques.
- Familiarity with CDISC standards (SDTM, ADaM) and clinical trial data structures.
- Excellent problem-solving skills, attention to detail, and ability to manage multiple tasks simultaneously.
- Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
- Certifications (optional):
- SAS Certified Statistical Programmer, or equivalent certification, is a plus.
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