Woodcliff Lake, NJ
We are currently searching for a skilled professional to join a well-known client’s team as SAS Programmer in Woodcliff Lake, New Jersey. The SAS Programmer role will play a significant part in the organization as they perform a variety of statistical analysis projects, and use their expertise for the benefit of the clinical community. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Reviews and gives feedback for SAP, TLG shells, and variable derivation rules
- Develops Study Quality Surveillance Plan and monitors study conduct to proactively address issues and ensure high quality study data
- Develops the Data Monitoring Committee Charter in collaboration with other functions and liaises with independent statisticians
- Reviews the SAP, provides feedback to the statistician, and collaboratively develops study specific dataset specs
- Performs and validates statistical analysis
- Independently reviews CSR’s and performs data interpretation
- Supports submission strategy planning, regulatory communication, and development of Health Authorities responses
- Creates and validates the eSubmission components (transport datasets for both SDTM & ADaM, Annotated CRF, define documents)
- Minimum 5 years of experience in the pharmaceutical, CRO, or biotech industry
- Strong SAS programming skills, with experience in SAS-Base, MACRO, STAT, and GRAPH
- Strong CDISC data standards, e.g. SDTM and ADaM
- Proven experience with UNIX and Windows operating systems
- Understanding of the software development life cycle
- Understanding of FDA guidelines
- Bachelor’s Degree required
- Master’s Degree in Biostatistics/Statistics preferred
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.