Senior Statistical Programmer

Voisin Consulting Life Sciences (VCLS); Lausanne; Vor Ort; CHF 80’000 - 120’000; Vollzeit

Zusammenfassung

A leading consulting company in life sciences is seeking a Senior Statistical Programmer for their Lausanne office. In this role, you will leverage your SAS programming expertise to lead key clinical study projects and ensure regulatory compliance. The position requires strong collaboration with biostatisticians and a commitment to Good Programming Practices. Ideal candidates will have extensive experience in SAS programming and a comprehensive understanding of CDISC standards.

Qualifikationen

• Minimum of 5 years in clinical trial programming in pharmaceutical or biotech.
• Experience with CDISC standards and GPP.
• Proficient in English, conversational French preferred.

Aufgaben

• Lead SAS programming efforts for clinical studies.
• Ensure regulatory submissions fulfill requirements.
• Collaborate cross-functionally to support programming deliverables.

Kenntnisse

SAS programming

CDISC standards

regulatory compliance

programming validation

collaborative skills

Ausbildung

Bachelor's or master's degree in Statistics, Computer Science, Engineering

Tools

SAS/Macro

SAS/SQL

Define-XML

Jobbeschreibung

4 weeks ago Be among the first 25 applicants

Voisin Consulting Life Sciences (VCLS) provided pay range

This range is provided by Voisin Consulting Life Sciences (VCLS). Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

Working as a Senior Statistical Programmer in our Lausanne, Paris, or Cambridge UK office, you will use your advanced SAS programming expertise and in-depth knowledge of industry-wide standards to lead and support clinical studies across all phases of development.

Reporting to the Director of Biostatistics, you will work closely with a small group of Biostatistician-Programmers to lead and support key aspects of the programming effort, ensuring the successful delivery of data and reporting components for various projects.

Responsibilities include, but are not limited to, the following:

Advanced SAS Programming Expertise

• Proficient in Base SAS, SAS/Macro, SAS/SQL; experience with SAS/Graph is a plus
• Demonstrated ability to develop, maintain, and troubleshoot SAS macro libraries
  
  

Strong Knowledge of CDISC Standards

• Hands-on experience with the implementation of SDTM and ADaM datasets
• Experience in Define-XML creation and CDISC validation tools such as Pinnacle 21
  
  

Regulatory Reporting Experience

• Direct involvement in generating outputs for periodic regulatory submissions (e.g., DSURs, PSURs, Annual Safety Reports)
• Working knowledge of FDA and EMA submission requirements
  
  

Lead and Validation Programming

• Experience leading programming efforts for the creation and validation of SDTM and ADaM datasets and statistical outputs (tables, listings, figures)
• Ability to conduct and document independent validation of programming deliverables
  
  

Standardization of Outputs

• Proven track record in building and maintaining a suite of standardized, reusable outputs and templates to support multiple studies
  
  

Collaborative and Communication Skills

• Comfortable working cross-functionally with statisticians, data managers, and clinical teams
• Strong documentation practices and the ability to communicate technical concepts clearly
  
  

Quality and Compliance Focus

• Commitment to Good Programming Practices (GPP) and regulatory compliance
• Strong attention to detail and thorough understanding of QC processes in a clinical trial settin
  
  

Requirements

• Bachelor's or master's degree in Statistics, Computer Science, Engineering, or a related field
• Minimum of 5 or more years of experience in clinical trial programming within the pharmaceutical, biotech, or CRO industry
• Advanced knowledge and experience in:
• SAS programming: experience in R is a major asset
• CDISC standards (e.g., CDASH, SDTM, ADaM) and industry best practices
• Technical and regulatory requirements related to the role
• Database set-up
• Clinical drug development
• Proficiency in English - conversational French would be a plus

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Analyst

• Industries

  IT Services and IT Consulting

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