Statistical Programmer

4 weeks ago

boston, United States eteraflex connects Full time

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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