The Senior Statistical Programmer will be responsible for supporting the SAS statistical programming efforts for specific projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs to meet the project’s needs. As part of the Statistical Programming team, this person will also provide technical expertise to the development of programming standards and procedures.
SCOPE AND RESPONSIBILITIES:
- Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data
- Generate SDTM domains, ADaM datasets, and Define.xml files
- Perform quality control for SAS programs and other study documents (e.g., presentations and reports)
- Document the quality control review process
- Review output across programs to ensure consistency
- Review, maintain, and approve study documents per standard procedures
- Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
- Program, test, and document global utility programs and tools in accordance with standards and validation procedures
- Provide technical oversight and leadership in the areas of analysis and reporting
- Participate in the development and/or maintenance of departmental procedures and standards
- Review CRFs, edit check specifications, and table mock-ups
- Assist in creation of table mockups under supervision of statisticians
- Serve as the primary project team representative, delegating work as appropriate
- Train and mentor new programmers
DESIRED SKILLS & EXPERIENCE
- BS degree in Statistics, Mathematics, or Computer Science or in a related field
- Minimum of 5 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer
- Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
- Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines
- Excellent communication and interpersonal skills to effectively interface with others
- Independent contractors are encouraged to apply
Agility Clinical appreciates recruiter interest; however, unsolicited resumes or calls from third parties will not be accepted at this time. Agility does not accept unsolicited resumes from outside recruiting firms. Any resume submitted in the absence of a signed agreement will become the property of Agility and no fee shall be due.
Agility Clinical is a small, but growing clinical research and consulting organization focused on conducting clinical trials in orphan diseases. We have a great working environment offering opportunities for advancement for individuals who have the right skills, initiative and motivation. If you are customer service oriented and have a passion for making a difference, then Agility may be the place for you.
Agility Clinical is a unique consulting and contract research organization dedicated to working with virtual, small biopharma and device...