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Principal Statistical Programmer

Remote, MA 01752

Posted: 01/09/2025 Employment Type: Contract Job Category: Data Sciences Job Number: 617004 Is job remote?: Yes Country: United States

Job Description

 
KEY RESPONSIBILITIES: 
?Lead on clinical studies and integrated analyses and provide guidance and training to other lower level personnel.
?Develop or evaluate software tools, SAS macros, utilities to automate programming activities and support Biometrics team collaboration.
?Contribute and implement to statistical analysis plans; provide additional expertise in the analysis of clinical trial when it relates to protocol development, case report form design and data collection.
?Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments.
?Work closely with Biostatistics to create analysis specifications following the instructions provided in Statistical Analysis Plan (SAP).
?Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer's Guide for Electronic Submission.
?Perform Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
?Interact with Statisticians and other clinical team, perform ad hoc analysis and generate outputs according to the requirements.
?Help identify issues and initiates resolution of the problems.
?Act as a liaison between statistical programming, subcommittees and project teams as needed.
?May serve as external spokesperson for the organization.
?Create/acquire tools to improve programming efficiency or quality control.
?Stay current with industry trend, best practices and improves statistical programming methodology.
?Other duties as assigned.  
 
PROFESSIONAL EXPERIENCE / QUALIFICATIONS: 
?Minimum 10 years Pharmaceutical/Biotech programming experience including macro/tools development experience.
?FDA submission experience is highly desirable.
?Strong SAS programming and Statistical background with strong skills in SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
?Ability to use professional concepts to achieve objectives in creative and effective ways.
?Experienced in managing multiple projects.
?Solid knowledge of SAS Programming language, Software Development Life Cycle and CDISC standards (SDTM & ADaM).
?Solid knowledge of other software such as R etc. is a plus. 
?BS/MS in Statistics, Math or Scientific Discipline.  

Minimum Degree Required: Bachelor's Degree

Pay ranges between $85-91.35/hr based on experience 

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 is an equal opportunity employer. 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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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.