Job Summary :
This essential team member will be responsible for supporting the statistical programming efforts for specific projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs. As part of the Statistical Programming team, this person will also provide technical expertise to the development of SAS programming standards and procedures.
ESSENTIAL FUNCTIONS:
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials .data in support of regulatory submissions and publications.
Generate SDTM domains, ADaM datasets, and Define.xml or Define.pdf files.
Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
Maintain complete and auditable documentation of all programming activities.
Review output across SAS programs to ensure consistency.
Provide statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
Assist in programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures.
Participate in the development and/or maintenance of departmental procedures and standards.
Review CRFs, edit check specifications, and table mock-ups.
Works effectively with cross functional groups, study team, and vendors.
Participates in monitoring CRO activities and reviewing CRO deliverables as necessary.
May assist in creation of table, figure, or listing mockups under supervision of statisticians.
May train and mentor new programmers.
Other duties as assigned.
QUALIFICATIONS:
Bachelor’s 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.
Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
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.
NDA submission experience is a plus.