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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