Syneos Health is a leading 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.
Clinical Development
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.
About Us
We are agile and driven to accelerate the delivery of therapies, because we are passionate about changing lives. Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Job Responsibilities
* Data Analysis and Reporting: Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.
* Quality Assurance: Works to ensure that outputs meet quality standards and project requirements.
* Programming Validation: Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings.
* Communication: Keeps project team members informed of programming progress and issues requiring their attention.
* Regulatory Compliance: Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
* Project Management: Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.
* Dataset Development: Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework.
* Meeting Management: Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus.
* Tech Support: Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
* Deliverable Management: Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions.
* Team Leadership: Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables.
* Documentation Review: Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities.
* sponsor Meetings: Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor.
* Mentoring: Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process.
* Technical Expertise: Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions.
* Industry Standards: Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures.
* Tool Development: Contributes technical expertise to the development of programming tools and macros for standardization and efficiency.
* CDISC Compliance: When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards.
* Compliance Reviews: When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML).
* Industry Updates: When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards.
* Transfer Deliverables: Transfers deliverables.
* Other Duties: Performs other work-related duties as assigned.
* Travel: Minimal travel may be required.
Qualifications
We are looking for individuals with:
* Education: Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience.
* Programming Experience: Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers.
* CDISC Knowledge: Knowledge and experience in the use of CDISC Standards for regulatory agency requirements. Experience in submissions to a regulatory agency preferred.
* Mentorship: Experience in mentoring others in clinical trial process and CDISC Standards.
* Communication Skills: Excellent written and verbal communication skills.
* Language Proficiency: Ability to read, write, speak and understand English.
We support a diverse, equitable and inclusive culture where everyone feels valued and empowered to contribute their best work. We encourage applications from qualified candidates who share our commitment to excellence and innovation.