Senior Biostatistician Job at Syneos Health, Inc., Raleigh, NC

S3JUNWtTQzhGK1didGVLN2trU1FhaVhiU3c9PQ==
  • Syneos Health, Inc.
  • Raleigh, NC

Job Description

INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical device industries. We do this across six continents, and we’ll do it for you too. Job Description Collaborates in the process of protocol development by choosing an appropriate study design, including statistical methodologies, calculating necessary sample size to achieve a pre-specified power, and writing the statistical section of the protocol. Sample size calculations may require some literature search to ensure that the study assumptions are correct. Writes and reviews Statistical Analysis Plans (SAPs) based on the protocol, including development of well presented mock-up displays for tables, listings, and figures. Collaborates with sponsor. Directs the activities of other Biostatistics personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other statisticians in the department. Participates in project teams as Biostatistics representative, interfacing as necessary with other departmental project team representatives. Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings. Creates or reviews programming specifications for analysis datasets, tables, listings, and figures. Participates in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting statistician. Conducts and participates in review and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP. Discusses time estimates for completion of study related activities with the Lead Statistician or Biostatistics management and proactively communicate to the Lead Statistician or Biostatistics management any difficulties with meeting these timelines. Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalates to management. Ensures proper study closeout by documenting and archiving study related materials according to Standard Operating Procedures (SOPs), and/or sponsor instructions. Generates and/or reviews randomization schedule(s) to ensure there are no errors present and sponsor and protocol requirements are met. Performs ongoing monitoring of actual randomization scheme applied by IVRS/IWRS. Displays willingness to work with others and assist with projects and business unit initiatives as necessary to meet the needs of the business. Qualifications MS or PhD in Biostatistics or related field. Moderate experience in clinical trials or equivalent combination of education and experience. Experience in SAS programming. Excellent knowledge of statistical theory including experimental design, categorical data analysis, analysis of variance (covariance), survival analysis, and nonparametric methods. Effective written and verbal communication skills. Ability to apply knowledge of basic statistical design, analysis, ICH guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts. Ability to read, write, speak, and understand English. Additional Information All your information will be kept confidential according to EEO guidelines. #J-18808-Ljbffr Syneos Health, Inc.

Job Tags

Similar Jobs

Get It - Hospitality

Director of Restaurant Operations - Remote | WFH Job at Get It - Hospitality

*Position: Director of Restaurant Operations** **Location:** Hybrid Remote - Primarily Remote, with one in-office day per week (NY, NY) **Reports To:** CEO **Salary:** $70,000-$90,000/year + Performance Bonuses **Employment Type:** Full-Time **Why Work Here?**... 

SysMind Tech

Atlassian JIRA, CONFLUENCE & TRELLO administrator Job at SysMind Tech

1. Extensive experience as a Atlassian JIRA, CONFLUENCE & TRELLO administrator, with hands-on experience configuring, supporting, and migrating the applications from one instance to another2. Extensive experience with scripting and programming is a plus such as Groovy1.... 

Clarity of South Central Indiana

Grant Manager Job at Clarity of South Central Indiana

 ...Description: Results Statement: I am accountable for producing the following results:Developing and managing a pipeline of current and prospective grant funders that align with Clarity's priorities. Through planned research, identification, development, cultivation... 

4th Day Trucking

CDL A, Home Weekly, Good Pay Job at 4th Day Trucking

 ...2-3 days for 34-hour reset Average Weekly Miles: 2,702 miles Annual Earnings: Average Driver earns $77,010+ per year Base Pay: $0.57 to $0.60 per mile Generous Pay: Mileage & MPG Bonus opportunities Top-Notch Trucks: 2020 & newer Peterbilts & Freightliners... 

Dayton Area School Consortium

Assistant Football Coach Job at Dayton Area School Consortium

 ...Building Date Available: 08/01/2025 District: Tri-Village Local Schools Tri-Village High School is looking for a varsity football assistant coach. This would be a paid coaching position. We would prefer that this position be filled by somebody who has...