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Biostatistician IV

Basking Ridge, NJ 07920

Posted: 12/13/2023 Employment Type: Contract Job Category: Data Sciences Job Number: 595064 Is job remote?: Yes Country: United States

Job Description


Target Pay Rate: 85-100/hr **salary will be commensurate with experience 

Job Description:

Position leads complex studies in study design, statistical analysis and interpretation of results with minimal supervision. Successful candidate needs to be able to operate at very high independent level. Experience on executing post hoc analysis is very important. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision. This position also guides contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses. Additionally, this position interacts with study teams, as well as statisticians and programmers at CROs. This position works under some supervision to solve complex study problems. Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Acts as main statistical contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.

Skills:

• Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments. • Significant knowledge of pharmacology, clinical research, and medical terminology and use it for study design and results interpretation. • Strong analytical and problem solving skills and able to provide guidance to lower level biostatisticians in solving problems. • Able to identify and investigate issues and causes independently and formulate potential solutions • Able to develop and execute strategic plans for drug or non-drug projects • Able to prioritize multiple tasks, develop instructions and manage vendors in completing the deliverables with high quality according to timelines, and provide recommendations to improve process • Compliant with internal and external compliance practice to ensure integrity of work and suggest innovative approaches to improve compliances and processes • Excellent programming skills in SAS and/or R and working knowledge of software such as nQuery, East, etc. • Excellent oral and written communication skills. • Working knowledge of clinical trial methodologies

Education:
  • PhD in statistics or biostatistics

**CO/NY candidates may not be considered 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Basking Ridge, NJ

Discover exciting job opportunities in the vibrant area surrounding Basking Ridge, New Jersey! Known for its picturesque landscapes, rich history, and thriving business community, Basking Ridge offers an unparalleled quality of life for professionals seeking growth and success. With easy access to NYC and iconic landmarks like the historic Jacobus Vanderveer House and the stunning Scherman Hoffman Wildlife Sanctuary, this charming region provides a perfect blend of career prospects and leisure pursuits. Indulge in locally sourced cuisine, catch a show at the elegant Ridge Performing Arts Center, or explore the natural beauty of Lord Stirling Park. Embrace the unique culture and endless possibilities that Basking Ridge has to offer as you explore our latest job listings and embark on a fulfilling career journey in this enchanting area.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.