Manager, SAS Programming

Organization
Aeras
Job Location
Rockville, MD
Job Description

Would you like to be a part of a dynamic, not-for-profit organization dedicated to a critical public health mission? Do you enjoy working in small teams, tackling a variety of responsibilities, and making a difference in peoples’ lives? We are a 150 person, $50 million, not-for-profit, integrated biotechnology organization focused on developing safe, effective vaccines to prevent tuberculosis, a major global health threat. We work in partnership with for-profit pharmaceutical companies and biotechs, academe and other non-profits, and are funded primarily by the Bill & Melinda Gates Foundation and various governments around the world. The Manager, SAS Programming, will manage CRO vendors for Aeras programming activities in support of Phase I - Phase IV clinical trials and provide supportive programming. If you learn quickly, are adaptable to change, and are eager to take on challenges, this could be a great opportunity for you 

POSITION SUMMARY: 

Manager, SAS Programming will manage CRO vendors for Aeras programming activities in support of Phase I - Phase IV clinical trials, and provide supportive programming as specified below. 

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

Vendor management 
- Design and monitor programming workflow of Aeras-contracted CRO to maximize efficiency for all clinical trial programming deliverables 
- Review resourcing estimates and timelines for CRO SAS programming activities 
- Review of external (third party) data transfers received; consult with CRO to integrate external data into study programming process flow 
- Review of SDTM and ADaM dataset specifications to ensure conformity to CDISC implementation guidelines and standards 
- Review SDTM and ADaM datasets prepared by CRO to ensure compliance with dataset specifications 
- Review tables, listings, and figures prepared by CRO to ensure quality and compliance with specifications 
- Design and maintain standard figure macros for use with Immunology and Assay Development data and by CRO 
- Provide/facilitate support as needed (technical, clinical) to ensure efficient action, collaboration and resolution 

Direct Programming Support 
- Provide SAS programming support to Immunology or Assay Development groups to assist with review of SAS datasets or other data 
- Program ad hoc data listings for QC audits, specialty Data Review meetings, or in response to requests by Data Management or Clinical groups 
- Review statistical analysis plans for all clinical trials 
- Perform vendor audits as required 
- Write and revise relevant department SOPs 
- Ensure compliance with department SOPs 
- Maintain all relevant programming documentation for designs, scripts and other processes 

SUPERVISORY RESPONSIBILITIES: 

No line management supervision; supervision of CRO as pertains to programming deliverables outlined above.

Requirements: 

Seven to ten years SAS programming experience (Base SAS, SAS/STAT, SAS/GRAPH and SAS macro language) in a biotech or pharmaceutical company, or in a contract research organization servicing the pharmaceutical industry. 
Experience supervising and/or mentoring SAS programmers 
Experience developing SAS macros systems 
Experience with database retrieval for data review and statistical programming on multiple platforms 
Experience in and recent training in Clinical Data Interchange Standards Consortium (CDISC) standards for programming of derived datasets 
Experience using the SAS Output Delivery System to output tables, listings and figures 
Proven ability to be innovative, set realistic timelines, and provide leadership as part of a clinical study project team 
Proven ability to implement GCP guidelines 
Excellent communication skills and ability to function as a lead team member on clinical trial project teams 
Familiarity with WHO-DRUG and MedDRA a plus 
BA or BS degree in Computer Science, Statistics, or related field

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