AddressDescription
Senior Clinical Programmer
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job responsibilities
The Clinical Database Programmer produces standard and custom reports for use by the Clinical Data Managers in their data review and cleaning efforts, develops transfer specifications with vendors for external data sources, and performs Study Data Tabulation Model (SDTM) conversion programming and Quality Control (QC).
• Extract clinical data from the clinical data management system and produce standard and custom reports, primarily in SAS.
• Program reports and listings as requested by project team members for ongoing studies.
• Develop transfer specifications with vendors for external data sources.
• Perform consistency checks on data transferred between Incyte and external parties to ensure completeness and accuracy of data contained transfers.
• Perform programming to convert raw, clinical trial data to Study Data Tabulation Model (SDTM) format.
• Perform Quality Control (QC) on programming work performed by fellow Database Programmers.
• Create and validate global macros or systems that streamline repetitive operations to increase programming efficiency
Qualifications
What we’re looking for
• Solid clinical SAS programming experience in the pharmaceutical industry.
• Working knowledge of CDISC SDTM mapping/specs/conversion/domains/datasets/eCRF/eCRT
Package/define.xml development and SDTM data transfer operations on clinical studies.
• Understanding of regulatory requirements relevant to submissions.
• Knowledge of clinical trial study design and electronic data submission requirements.
• Communication and interpersonal skills and the ability to work effectively as part of a team.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
