We have a current opportunity for a Manager/AD Standards Statistical Programming Role on a permanent basis. For further information about this position please apply and let's have an open discussion.
Job Title: Manager/Associate Director, Statistical Programming Standards
Job Type: Full-Time
Department: Biostatistics and Programming
Job Summary: We are seeking an experienced Manager/Associate Director of Statistical Standards Programming to join our dynamic team. The successful candidate will be responsible for developing and maintaining programming standards, ensuring compliance with regulatory requirements, and providing expertise in R and SAS programming. This role will involve collaboration with cross-functional teams to support clinical trials and other research activities.
Key Responsibilities:
- Develop, implement, and maintain statistical programming standards and guidelines.
- Ensure compliance with regulatory requirements and industry best practices.
- Provide expertise in both R and SAS programming to support clinical trial data analysis and reporting.
- Collaborate with biostatisticians, data managers, and other stakeholders to ensure the quality and consistency of statistical programming deliverables.
- Lead the development and maintenance of standard macros, templates, and tools to improve efficiency and quality.
- Provide technical leadership for statistical standards
- Accountable for utilizing statistical methods for data analysis, providng R Packaging
- Review and approve programming deliverables to ensure adherence to standards.
- Stay current with industry trends and advancements in statistical programming and regulatory requirements.
Qualifications:
- Bachelor's or Master's degree in Statistics, Computer Science, or a related field.
- Minimum of 5 years of experience in statistical programming within the pharmaceutical or biotechnology industry.
- Clinical trial experience in early/late stages
- Expertise in both R and SAS programming languages.
- Strong knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., CDISC).
- Excellent problem-solving skills and attention to detail.
- Strong communication and interpersonal skills.
- Ability to work effectively in a team-oriented environment.
- Experience with clinical trial data and ICH/CDASH/CDISC standards (SDTM, ADaM, TFL) is highly desirable.
Preferred Qualifications:
- Master's in Statistics, Computer Science, or a related field.
- Experience in a leadership role within statistical programming.
- Knowledge in other statistical programming languages/software like Spotfire, WinBUGS, Python, , etc
Benefits:
- Competitive salary and benefits package.
- Opportunities for professional development and career advancement.
- Collaborative and inclusive work environment.
