About Syneos Health
We are 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
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.
Collaborative Work Environment
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.
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
* Develop custom programming code using SAS or other software to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.
* Ensure outputs meet quality standards and project requirements.
* Perform validation programming and work with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings.
* Keep project team members informed of programming progress and issues requiring their attention.
* FOLLOW applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
* Maintain well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.
* Manage 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.
* Develop specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipate and address 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.
* Conduct effective internal meetings (appropriate in format, frequency and attendance). Distribute relevant information in advance. Ensure minutes are promptly and accurately distributed. Follow action items through to completion, and maintains order and focus of meetings, working toward consensus.
* Display willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
* Accountable for on-time delivery across concurrent programming deliverables. Negotiate 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.
* Act as the lead statistical programmer. Direct the programming activities of other programming personnel and monitors progress on programming deliverables.
* Review project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provide feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities.
* Participate in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor.
* Contribute to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process.
* Maintain a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serve as a technical expert resource to other department members for complex programming questions.
* Work cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures.
* Contribute technical expertise to the development of programming tools and macros for standardization and efficiency.
* Serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provide guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards.
* Serving as a subject matter expert for CDISC and other industry and regulatory requirements, perform 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).
* Serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participate in industry standards organizations and provide regular updates to the Biometrics Department on upcoming changes to those standards.
* Transfer deliverables.
* Perform other work-related duties as assigned.
* Minimal travel may be required.
Qualifications
We are seeking a candidate with:
* An undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated 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.
* Knowledge and experience in the use of CDISC Standards for regulatory agency requirements. Experience in submissions to a regulatory agency preferred.
* Experience in mentoring others in clinical trial process and CDISC Standards.
* Excellent written and verbal communication skills.
* Ability to read, write, speak and understand English.
About Us
At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we take into consideration transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.
Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients' lives around the world.