Senior Biostat Programmer

Senior Clinical Programmer    
Duration: 12 Months
Remote/Prefer in EST (Open for all Over USA)

Core essential skill sets that candidates must have:

1. Minimal Bachelor’s degree in any field
2. Over 5 years of SAS software knowledge
3. 3 to 5 years SDTM/SDTM IG 3.3/3.4 experience
4. 3 years experience being responsible for creating mapping specs between RAW CDMS data to SDTM
5. 5 years experience being responsible for creating SAS programs that map raw CDMS data to SDTM

• What are the core essential skill sets you are looking for candidates to have to be considered for the role? See experience profile shown below
• Projected Start date (Average 3 weeks for screening clearance): Before the end of April
• Duration of Contingent Assignment: December 31, 2025
• Is this temp to perm? At this time, No
• Is this a Per Diem project? No, hourly based (40 hours/week)
• Number of open positions: 1
• Job Title: Senior Programmer (SDTM focus)
• Shift schedule: US timezone 8 hours/day – preferably East Coast
• Onsite or remote: Remote/ Prefer in EST (Open for all Over USA)

• Position Title:     Senior Clinical Programmer    
  Department:     Clinical Programming 
   
  Position Summary:   
  The Senior Clinical Programmer is responsible to provide high level skills of clinical programming support of clinical projects and regulatory submissions. The Senior Clinical Programmer is playing a lead role generating and validating analysis datasets, tables, listings and figures. The Senior Clinical Programmer is responsible for providing professional expertise and leadership by supporting departmental tasks and initiatives in improving clinical programming processes with focus on SAS Programming.
   
  Travel Requirements:  Limited as job tasks are required 
   
  Essential Duties & Responsibilities: 
  1.     Primarily work  at the project level  
  2.      Provides input necessary to support budget planning when required
  3.     Delivers assignments with quality and within timelines 
  4.     May provide training to others as needed. 
  5.     Leads/co-leads clinical programming for a study or for a regulatory submission
  6.     Develops, reviews, documents and performs validation of generic SAS macros
  7.   Supports new processes, new methodologies and operational ideas; comfortable in challenging existing ones to assist programming group improve the effectiveness and efficiency of services provided. 
      
  Position Requirements: 
  Education Required:     
  Bachelor’s Degree/Master’s Degree/PhD in Science, Statistics, Information Technology or equivalent combination of education and related work experience.
  Experience Required:     
  Bachelor’s Degree 3 years or Master’s Degree 2 years in Science, Statistics, Information Technology or equivalent combination of education and related work experience.     
  
  Experience Preferred:     
  Experience in SDTM and ADaM acquainted with CDISC Guidelines and requirements. 
  Specialized or Technical Knowledge Licenses,
  Certifications needed:      
  Functional Knowledge:     
  Intermediate level of SAS programming skills. Perform complex SAS programming and QC tasks. Solid knowledge of CDISC data standards. General understanding of statistical concepts. Good understanding and ability to resolve Pinnacle 21 report findings. Create data submission package. 
  
  Company/Industry Related Knowledge:     
  Good knowledge of government regulations pertaining to drug development.
   
  Job-Specific Competencies:   
  1. Works to agreed strategy under high level of oversight. 
  2. Identifies issues, proposes solutions and actively engages others to resolve issues. 
  3. Clear and effective communication; possible to provide input on process development and improvement. 
  4. Ability to work under pressure and multitask