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Senior Biostatistician for Clinical Trial Development
3 weeks ago
At Syneos Health, we are dedicated to accelerating customer success in the biopharmaceutical industry.
We achieve this by translating unique clinical, medical affairs and commercial insights into outcomes that address modern market realities. Our Clinical Development model puts the customer and patient at the center of everything we do.
We strive to simplify and streamline our work to make Syneos Health easier to work with and 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 who innovate 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 about changing lives. Discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE
Why Choose Syneos Health?- We develop our people through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We have a Total Self culture where you can authentically be yourself. This culture unites us globally, and we take care of our people.
- We continuously build the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels like they belong.
- You will use 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.
- You will ensure that outputs meet quality standards and project requirements.
- You will perform validation programming and work with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings.
- You will keep project team members informed of programming progress and issues requiring their attention.
- You will follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g., ICH).
- You will maintain well-organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.
- You will manage scheduling and time constraints across multiple projects at a time, set goals based on priorities from management, and adapt to timeline or priority changes by reorganizing daily workload.
- You will develop specifications for datasets and outputs of any complexity according to statistical and sponsor requirements. You will anticipate and address potential programming issues, reflect forethought, establish the basis for efficient programming, and accurately define all variables to be accepted by peer review and sponsor/requestor with little rework.
- You will prepare in advance for internal meetings, contribute ideas, and demonstrate respect for opinions of others.
- You will 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 maintain order and focus of meetings, working toward consensus.
- You will display willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
- You will negotiate and establish accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and complete project programming activities within timeframe allotted.
- You will act as the lead statistical programmer. Direct the programming activities of other programming personnel and monitor progress on programming deliverables.
- You will 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.
- You will participate in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor.
- You will 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.
- You will transfer deliverables.
- You will perform other work-related duties as assigned.
- You may require minimal travel.
