We are looking for an experienced Senior Clinical SAS Programmer to join our team!
Remote applicants are welcome to apply.
The Senior Clinical SAS Programmer is a core member of the Biostatistics and Programming group. A person in this role is responsible for performing all SAS programming tasks required to support the planning and execution of statistical analysis and reporting of projects, and acts as the lead statistical programmer on multiple projects.
The position requires strong background in the reporting of clinical trial data, using SAS, for use in the pharmaceutical industry and familiarity with the development and conversion of datasets to meet CDISC standards including SDTM and ADaM.
In this position you will:
- Lead the development of statistical programming for analysis datasets, tabulations, graphics, and listings from clinical trial databases and other clinical data sources.
- Lead the development of specifications that define program requirements used to generate analysis datasets, tables, listings and figures and ensure they are consistent with the goals of the project, statistical analysis plans and applicable CPC and regulatory guidance. In addition, may oversee multiple studies and or the development of specifications for extensive ad hoc, academic or publication strategies.
- Provide support for the development of specifications and programming for operations activities such as data transfers, edit checks and trending reporting based on specifications.
- Oversee the development, validation and execution of SAS for the reporting and presentation of data, reconciliation of data sources, integrity and consistency checks of clinical data and development of derived datasets to meet client needs.
- May lead efforts to incorporate innovative technologies for automation of operations activities and develop tools for enhancing operations in new and evolving areas.
- Serve as a resource for cross-departmental consultation on the development and innovation of new ideas and challenges.
- Provide insightful feedback on ad hoc requests as needed to meet client needs.
- Provide high quality time-oriented solutions to new and innovative situations which may arise from academic or publication initiatives.
- May lead the adoption of new and evolving CDISC standards and technologies.
- Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results and provide insightful feedback on ad hoc requests as needed to meet client needs.
- Review and assist with maintenance of existing SAS programs as needed.
- Clearly communicate technical or complex programming challenges to identify quality solutions.
- May lead development of standardization of programming methods including departmental standards, global use macros and program libraries.
- Review statistical analysis plans and provide thoughtful comments to enhance displays and efficiencies to meet the needs of the project and meet CDISC, regulatory and CPC requirements of standards and formatting. Independently develop reporting plans for tasks as appropriate (e.g., edit checks, trending reports, quality reports).
- Perform user acceptance testing to ensure quality and alignment with study needs. May serve as an expert contributor in the development of new and evolving expertise or technologies.
- Provide programming review of CRF and perform user acceptance testing to ensure adherence to regulatory and CDISC standards and ensure alignment with study goals.
- Establish and maintain a positive relationship with the study team that fosters confidence, facilitates problem resolution, and enhances the integrity of data and deliverables.
- Effectively lead programming effort and ensure documentation is complete.
- Effectively communicate requirements, timelines and progress of deliverables/projects. May also coordinate external resources or budgets and assist in identifying expertise or technologies for new and evolving areas.
- Prepare, document and test required programs and procedure data displays in an efficient manner for inclusion in integrated clinical, statistical reports and other similar reports.
- Work collaboratively with lead biostatistician to ensure deliverables are of high quality delivered on time and challenges are addressed or raised for appropriate action.
- Lead development of department and company standards in programs, datasets and directory structure. May also act as expert in specific technologies for new and evolving areas or act as consultant to other CPC departments.
- Lead development of standardization and programming methods including display standards, global use macros etc.
- Remain current on new SAS developments by attending user group meetings, reading SAS related publications, taking SAS courses and/or interfacing with SAS institution personnel.
- Coordinate multiple programming resources (e.g., CROs or contractors) are used.
- Provide oversight of others including external programming resources.
- Serve as a leader in the department and resource for other programmers in the development and adoption of standards for programming methods including programming libraries and global use macros.
Here’s what you will need to bring to the table:
- A degree in a related field or SAS certificate. Master’s degree is preferred.
- A minimum of 8 years of experience programming in SAS (v9.2+), preferably in a Windows environment.
- Extensive programming experience with SAS macros, ODS, Reporting, Graphics, proc SQL, Microsoft Access, and Excel.
- A minimum of 6 years pharmaceutical/CRO experience as a SAS programmer supporting clinical trials for regulatory submissions is highly preferred.
- Significant experience leading programming efforts, such as the development and conversion of datasets to meet CDISC standards including SDTM and ADaM.
- Proficiency with SDTM and ADaM standards, tables, listings and graphs in support of pharmaceutical product development.
- Proficiency in all basic SAS computing functionality and common data summarization and analysis strategies and procedures aligned with CPC standards.
- Expertise in specific areas, such as complex macro programming, enhanced graphics display, other programming languages e.g., R, Python is a plus.
- In-depth understanding of regulatory, industry, and technology standards and requirements.
- Good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs.
- Demonstrated ability to work in a team environment with clinical team members.
- Impeccable attention to detail.
- Excellent analytical, organizational, communication and team skills.
Note: Viable applicants will be required to pass a background and education verification check.
Targeted Compensation: $93,000 – $120,000 annually
About CPC:
CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 30 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more.
CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.
CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. http://www.cpccommunityhealth.org/
CPC offers:
- Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
- Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)
- 10 paid holidays
- 15 – 25 vacation days based on years of service
- Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)
- In-suite exercise and relaxation room
- Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
- Flexible and remote work schedules
An Equal Opportunity Employer
CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, sex, gender identity, veteran status, marital status, sexual orientation, age forty and over, disability, genetic information or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.
Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at careers@cpcmed.org.