Posting Date: June 7, 2017
Position: Sr. SAS Programmer
Location: Clovis Oncology, Inc., Boulder, CO
The Sr/SAS Programmer will work with statistical and data management colleagues to develop SAS programs for the presentation and review of clinical trial data.
- Working independently, or with other statistical departmental members, or consultants, to develop effective statistical outputs applicable to project;
- Preparation of the statistical results for clinical study reports (CSR), and production of overall summaries (e.g., Annual Safety Reports);
- Assist in the design and testing of clinical databases;
- Review edit checks
- Assist in the review of clinical databases by creating edit checks as part of a data quality review
- Coordinate the transfer of and review data from outside vendors (CROs, central labs);
- Perform user acceptance testing on database applications;
- Perform SAE reconciliation between the clinical database (AE) and the Drug Safety database (SAE), as applicable;
- Effectively works with Clinical Research Organizations (CROs) to ensure high-quality deliverables within timeline and budget;
- Providing general guidance on definition and documentation of key derived variables needed to support production of tables, listings, and graphs;
- Maintaining awareness of industry standards, regulatory requirements, and departmental guidelines;
- Senior level: may provide work direction/guidance to other programming personnel
Education and Experience
- A B.A. or B.S. in statistics or related discipline and 3+ years of pharmaceutical experience
- Senior level: A B.A. or B.S. in statistics or related discipline and a minimum of 5+ years of pharmaceutical experience
- At least 1 year experience in Oncology
- Office-Based position; minimal travel required
Posting Date: December 20, 2016
Position: Clinical SAS Programmer
Location: CPC Clinical Research, Aurora, CO
The Clinical SAS Programmer is a core member of the Biostatistics & Statistical Programming group.
In this position you will:
- Support high quality and efficient development, validation and execution of SAS programs in accordance with established specifications
- Perform ad hoc flexible and rapid programming
- Contribute to the preparation and review of analysis plans
- Provide programming input to CRF, SAP, analysis file specifications
- Establish and maintain a positive relationship with study teams
- Ensure compliance with GCP, FDA and ICH guidelines and CPC standards
- introduce new technologies or procedures to facilitate and optimize functionality
- Contribute to the creation, maintenance, and validation of macros for standard outputs and programming
Here’s what you will need to bring to the table:
- A degree in a related field or SAS certificate (preferred)
- Minimum of 4 years of experience programming in SAS (v9.0+) in a Windows environment
- Minimum of 4 years of experience working in the pharmaceutical or biotechnology industry or other regulated healthcare setting
- Demonstrable programming experience with SAS macros, ODS, Reporting, Graphics, proc SQL, Microsoft Access, and Excel
- Significant experience with development and conversion of datasets to meet CDISC standards including SDTM and ADaM (preferred)
- Proficient with SDTM and ADaM data, tables, listings and graphs in support of pharmaceutical product development
- Excellent organizational and team skills
- Attention to detail
- Demonstrated ability to work in a team environment with clinical team members
Note: Viable applicants will be required to demonstrate their computer skills as well as pass a background check.
Please include a short cover letter with answers to the following questions:
- Why would you be a good candidate for this position?
- How many years of programming experience do you have?
- Any gaps in your employment history? Please explain.
- What are your salary expectations?
CPC is an academically led clinical 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 25 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's proprietary database contains more than 1000 clinical investigators located throughout the world.
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 a comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
Visit our web site to learn more about us and values we embrace: www.cpcmed.org
To Apply: firstname.lastname@example.org