Syneos Health · 4 weeks ago
Senior Statistical Programmer(SDTM,ADAMS,TLF)
United States
Full-time
Remote
Senior Level
5+ years expSyneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. The Senior Statistical Programmer will develop custom programming code, ensure output quality, manage project documentation, and lead programming activities while collaborating with team members to meet project goals.
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 and 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
Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others
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. Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted
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. 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 a degree, an equivalent combination of education and demonstrated programming experience will be considered
Must have 5+ years of end-to-end Statistical Programming experience, covering SDTM development, ADaM dataset creation, and TLF outputs
Lead or Co-Lead study experience is mandatory, with the ability to independently manage study-level deliverables
Must have Basic proficiency in R programming
Excellent written and verbal communication skills
Ability to read, write, speak and understand English
Preferred
Immediate joiners will be preferred
Benefits
Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Company
Syneos Health
Syneos Health, the only fully integrated end-to-end clinical and commercial solution organization.
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
2025-12-01
Company data provided by crunchbase