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15 days old

Remote - Principal Statistical Programmer (Oncology)

Kelly Services
Indianapolis, IN 46202 Work Remotely
**Kelly Science** is looking for great individual to join as Principal Statistical Programmer related to oncology clinical studies. Reporting to Senior Director in Statistics. Will work closely with cross-functional teams on single possibly multiple clinical development programs.


**Remote - Principal Statistical Programmer,** (Remote with some travel for team or client meetings


**Direct Hire**


+ Typical requests include internal ad-hoc requests, periodic safety and efficacy updating report, TLF output supporting presentations, publications and health authority submissions.

+ The Principal Statistical Programmer for Early Stage will be responsible for providing timely support to the study team on all programming requests, including internal programming deliverables requested by POINT study team and oversight of CRO statistical programming activities.


**Responsibilities:**


+ Demonstrate extensive understanding of SAS programming concepts and techniques in pharmaceutical/biotechnology setting, independently develop, test, and document SAS programs and macros for programming deliverables. Create, maintain the programming specifications for the data sets, review the programming specifications provided by CRO.

+ Create and validate SAS outputs including SDTM and ADaM datasets, and TLFs or ad-hoc output per study team request.

+ Responsible for the creation of patient profile and clinical summary report package.

+ Understand and perform in accordance with regulatory standards.

+ Create and validate SAS outputs supporting presentations, publications and health authority submissions


**Requirements:**


+ MS in mathematics, statistics or related analytic field.

+ Minimum 7 years of hands-on statistical programming experience in CRO, biotech, or pharmaceutical setting, including SAS/BASE, SAS/STAT, SAS/GRAPH and SAS Macro languages.

+ Open to traveling 10 within North America for team building event Working knowledge in all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of related disciplines, biostatistics, statistical programming and CDM.

+ Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define package, reviewer s guide and submission standards.

+ Working knowledge GCP/ICH standards, 21 CFR Part 11 and FDA requirements with prior experience filing NDA/MAA/BLA preferred.


**Competencies:**


+ Demonstrates leadership, flexibility, critical thinking, time management and problem-solving skills.

+ Ability to work independently, while being a collaborative team member in a dynamic fast-paced and lean environment.

+ Motivated learner who is looking to advance own experience.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-05-13 Expires: 2022-06-13

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Remote - Principal Statistical Programmer (Oncology)

Kelly Services
Indianapolis, IN 46202

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