Job Description
Job Description 40 h/w - Remote Contract - Sas Programmer: Collaborate with the Biostatistics team by performing programming tasks and partnering with clinicians, programmers, study teams, and publication managers to produce and validate outputs. Ensure accurate and timely programming and validation for clinical studies and publications. Review abstracts and manuscripts to confirm statistical methodologies are applied appropriately and oversee external vendors as required.
Key Responsibilities: - Provide programming and validation support for clinical study reports and publications. Manage external vendor programming activities and coordinate efforts among team programmers to meet deadlines for tasks such as creating SDTM datasets, ADaM datasets, statistical tables, figures, listings, and other requests. Support the clinical study team in designing and reviewing study protocols.
- Create and/or review statistical analysis plans, including shell designs for tables, listings, and figures, as well as final study reports. Perform post-hoc statistical analyses as needed. Collaborate with clinicians, statisticians, and publication managers to produce and validate publication outputs and ensure the integrity of statistical methodologies in manuscripts and abstracts.
- Partner with statisticians and clinical data managers to design and review case report forms, data transfer specifications, and edit check specifications. Participate in user acceptance testing (UAT), and coordinate data review meetings to uphold data quality throughout the study lifecycle.
- Contribute to database and case report form development, including edit check programming and feedback for Data Management. Provide input for statistical analysis plans, dataset specifications, validation plans, and related documentation.
- Work independently to achieve objectives, introduce process improvements, and uphold programming standards.
- Supervise CRO programming efforts, conduct quality assurance checks on SAS-generated tables, listings, and figures, and ensure the quality of external deliverables. May contribute to submission teams in a programming or statistical role.
Qualifications and Requirements: - A Master's degree in Biostatistics, Statistics, or a related field is preferred, along with at least 7 years of experience in the pharmaceutical, biotech, or CRO sectors.
- Proficient in SAS programming, including SAS-Base, MACRO, STAT, and GRAPH.
- Familiarity with CDISC standards such as SDTM and ADaM.
- Strong technical writing and communication skills, both verbal and written.
- Exceptional organizational skills, with the ability to manage multiple projects simultaneously.
- Demonstrated ability to work both independently and collaboratively within a team setting.
- Hands-on experience with UNIX and Windows operating systems.
- Knowledge of the software development lifecycle and FDA guidelines.
- Excellent attention to detail, time management, and the ability to work effectively under tight deadlines.
Job Tags
Contract work, Remote job,