Stat Programmer II / Sr Stat Programmer / Prin Stat Programmer

Description

Syneos Health is 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 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.

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.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Why Syneos Health

JOB SUMMARY

This position functions as a member of the Biostatistics and Statistical Programming project team serving as a Lead Statistical Programmer for projects of any complexity in the development of programs to support the conduct, statistical analysis and reporting of projects; creates, tests, and maintains programs for clinical studies, coordinating the efforts of other programming personnel; determines the overall strategy for the programming tasks on a project; assists in managing project budgets and tracking project specific performance metrics; functions as an internal and external customer liaison; provides input to the statistical analysis plan; leads the creation and maintenance of statistical programming project documentation.

JOB 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.

Qualifications

What we re looking for