(Senior) Manager* Statistical Programming - REMOTE
Proclinical is seeking a remote (Senior) Manager* Statistical Programming for a cutting-edge biotech company.
Must be eligible to work in the US.
- Work collaboratively with Clinical Development team or CRO to meet project deliverables and timelines for statistical data analysis and reporting
- Independently perform or oversee the production and/or validation of programming deliverables (e.g., analysis datasets, tables, listings) for study reports and integrated summaries
- Anticipate resource needs and works with management to ensure adequate long-term resource allocation within a therapeutical project
- Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with company quality standards, ICH-GCP and/or other international regulatory requirements
- Participate in development of a global programming standard library to enable consistent and efficient project deliverables across portfolios; develop tools for efficient production and verification of derived datasets, e.g., SDTM and ADaM, and TLFs
- Provide functional expertise in the development and implementation of centralized clinical data repository, clinical data dictionary, and operational data dictionary
- Collaborate with Biostatistics to develop, implement and maintain appropriate statistical applications such as data review and reporting tools
- Provide programming support to the regulatory submissions including data submission package and define.xml development
Skills and Requirements:
- BSc in Statistics, Mathematics, Computer Science, or related discipline, advanced degree preferred
- 5+ years (3+ years for advanced degree) experience in a pharmaceutical industry, CRO or another clinical research setting
- Strong competence in statistical programming including SAS/Base, Macro, STAT, GRAPH, SQL, etc.
- Good understanding of FDA, EMA, ICH, and global regulations and guidelines
- Solid knowledge and experience of industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards
- Oncology or Infectious Disease therapeutic areas and submission experience is preferred
- Project management experience, detail-oriented, and strong organizational and communication skills in English (written and Spoken)
- Ability to work in a fast-paced, dynamic team environment as well as strong analytical and problem solving skills
If you are having difficulty in applying or if you have any questions, please contact Merna Hermiz at +(1) 323-306-2409 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.