Principal Statistical Programmer (SDTM, ADAM &TLF)

Syneos Health; United States; Remote; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a lead statistical programmer to develop and validate programming code for statistical outputs. This role involves collaborating with biostatisticians and project teams to ensure quality and compliance with regulatory guidelines. The successful candidate will manage multiple projects, mentor junior staff, and contribute to internal meetings. If you are passionate about statistical programming and looking to make a significant impact in a dynamic environment, this opportunity is perfect for you.

Qualifications

• Experience in SAS programming and statistical analysis.
• Ability to manage multiple projects and meet deadlines.

Responsibilities

• Develop custom programming code to generate statistical outputs.
• Ensure quality standards and project requirements are met.
• Lead programming activities and mentor junior programmers.

Skills

SAS Programming

Statistical Analysis

Data Validation

Project Management

Documentation

Education

Bachelor's Degree in Statistics or related field

Master's Degree in Statistics or related field

Tools

SAS

Statistical Software

Job description

Role & 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