Syneos Health · 2 weeks ago
Pr Statistical Programmer-ADAM/TLF(Oncology)
United States
Full-time
Remote
Senior LevelSyneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. The Pr Statistical Programmer will develop custom programming code to generate statistical outputs, ensure quality standards, and lead programming activities while collaborating with cross-functional teams.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
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. Works to ensure that outputs meet quality standards and project requirements
Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. · Keeps project team members informed of programming progress and issues requiring their attention
Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH)
Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness
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
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
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
Displays 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. 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
Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables
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
Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor
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
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
Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures
Contributes technical expertise to the development of programming tools and macros for standardization and efficiency
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
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)
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
Transfers deliverables
Performs other work-related duties as assigned
Minimal travel may be required
Qualification
Required
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
Excellent written and verbal communication skills
Ability to read, write, speak and understand English
Preferred
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
Benefits
Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Total Self culture
Company
Syneos Health
Syneos Health, the only fully integrated end-to-end clinical and commercial solution organization.
Founded in 1985
10001+ employees
H1B Sponsorship
Syneos Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (35)
2024 (26)
2023 (49)
2022 (63)
2021 (84)
2020 (63)
Funding
Current Stage
Public CompanyTotal Funding
$524.65M2023-09-28Private Equity
2023-05-10Acquired
2021-03-01Post Ipo Secondary· $524.65M
Leadership Team
Michael Bonello
Executive Vice President and Chief Financial Officer
Michael Brooks
Chief Operating Officer
Recent News
2026-01-09
2025-12-01
Company data provided by crunchbase