At ANCORE we strive to create an environment where our people come first. We call our employees members to reinforce that all who join our team are considered company owners and are empowered to share in the rewards and challenges that come from building a world-class business. As one of the largest independent information technology and business process services firms in the world, we realize our continued success depends on our ability to attract and retain top-quality professionals like you.
- Review protocols for CDISC conformance.
- Review Case Report Forms and eCRFs with CDISC CDASH and SDTM conformant elements.
- Write and manage SAS code for mapping clinical data to SDTM data structures in conformance with Emmes' SDTM Implementation Guide, project standards, and the study protocol.
- Create DEFINE specifications for mapping of SDTM and ADaM compliant datasets.
- Review and QC submission ready SDTM datasets, define.xml, and supporting documentation, as appropriate.
- Provide CDISC training and serve as a subject matter support to project staff.
- Maintain and coordinate CDISC standards efforts, ensure maximum reuse of applied standards, involvement in ongoing process improvement efforts and working with teams to provide technical and process guidance.
- Stay current with the evolution of all CDISC standards and be involved in creation and maintenance of process documentation.
- Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations.
- Good understanding of the statistical programming domain and related processes.
- Assists with developing, monitoring, and enforcing productivity and quality standards along with related documentations.
- Coordinating with the project management in meeting the timeline and defining/ capturing the metrics for monitoring and maintaining the quality and productivity.
- Bachelor's or Master's degree in Computer Science, Management Information Systems, or a related field.
- Minimum of 5 years of experience in using SAS to process and analyze large datasets.
- Experience in conducting data quality reviews including clinical data, tables, graphs, and reports.
- Experience in developing technical documentation.
- SAS Certified Base Programmer certification required.
- Experience with development, documentation, and testing of analysis data and programming code to meet regulatory and company standards.
- Good organizational and communication skills, the ability to work in a collaborative environment, and a desire to improve skills are essential.
We offer great benefits – Competitive Paid Time Off, Medical, Dental and Vision Insurance, 401(k).
We invest in our employees – Every employee is provided with a stipend to invest in certifications, a master’s degree, or even a doctorate. We want you to grow as an expert and a leader and offer flexibility for you to take a course, a certification, or attend a conference. We are committed to supporting your curiosity and sustaining a culture that prioritizes commitment to continuous professional development.
We work hard, we play hard. Ancore is committed to injecting fun into every day. We dedicate funds for activities – virtual and in-person – e.g., we host happy hours, holiday events, fitness events, and annual celebrations. In alignment with our commitment to our communities, we host and attend charity galas/events. We believe in appreciating your commitment and building a positive workspace for you to be creative, innovative, and happy.
Ancore Inc is an Affirmative Action/Equal Opportunity employer. As such, any personnel decisions (hire, promotion, job status, etc.) on applicants and/or employees are based on merit, qualifications, competence and business needs, not on race, color, citizenship status, national origin, ancestry, gender, sexual orientation, gender identity, age, religion, creed, physical or mental disability, pregnancy, childbirth or related medical condition, genetic information of the employee or family member of the employee, marital status, veteran status, political affiliation, or any other factor protected by federal, state or local law.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
