Biotech/Pharmaceutical

Senior/Principal Statistical Programmer

Permanent

Penfield Search Partners

Contact: Linda Aronova – laronova@penfieldsearch.com

Job Description: Supports the clinical drug research and development process by providing strategic statistical programming planning and execution, including data transformation, data analysis and data reporting.

Tasks & Responsibilities:

  • Senior/Principal Clinical Data Scientist with focus on Statistical Programming
  • Provide comprehensive statistical programming support to clinical trials and projects.
  • Ensure quality of BDS deliverables by consistently applying analysis and reporting standard.
  • Ensure compliance with company and department SOP’s, FDA/ICH/GCP regulations and CDISC standards.
  • Develop robust programming specifications for internal and external programming work
  • Independently develop, troubleshoot, and maintain programs and utilities to support the creation and validation of datasets and outputs
  • Support/guide other colleagues, internal and external customer, and external providers on data science related tasks
  • Support the development and implementation of innovative strategies and technologies for data science within and outside of company
  • Participate in cross-functional human pharma internal working-groups or lead cross-functional BDS internal working-groups and drive/plan relevant data science aspects.
  • Collaborate closely with scientists and experts from various disciplines in clinical development.
  • Enhance business knowledge and scientific expertise in a global environment.
  • Exchange expertise in data science community.
  • Principal Clinical Data Scientist with focus on Statistical Programming
  • In addition, lead and oversee statistical programming in complex phase I-IV clinical trials or projects.

Requirements:

  • Bachelor of Science (BSc) from an accredited institution in Statistics, Mathematics, Computer Science, or related field (Psychology, Data Science, Finance, etc.) with a minimum of five (5) years of data science experience; Or
  • Master of Science (MSc) from an accredited institution in Statistics, Mathematics, Computer Science or related field (Psychology, Data Science, Finance, etc.) with a minimum of three (3) years of experience within the pharmaceutical industry, CROs, regulatory authorities or academic institutions; Or
  • Doctoral Degree (PhD) from an accredited institution in Statistics, Mathematics, Computer Science, or related field (Psychology, Data Science, Finance, etc.
  • Advanced knowledge and hands-on experience in relevant software languages in recent years, in particular SAS. Additional R programming skills are of advantage
  • Sound knowledge of CDISC standards, design of clinical trials or clinical experiments, basic medical terminology and processing clinical trial information
  • Experience in clinical trial and drug development
  • Experience in working in/with agile teams and/or as a product owner is a plus
  • Ability to pro-actively identify issues and solutions, interact with internal and external team members on routine clinical data science issues
  • Interpersonal skills. Interact effectively with people, internally and externally (e.g., CROs, experts, management) as well as evidence of strong teamwork, also in global and remote context.
  • Oral and written communication skills to interact in interdisciplinary teams as well as the ability to explain, visualize and communicate complex data science aspects
  • Fluency in written and spoken English

Additional requirements for a Principal Position:

  • Bachelor of Science (BSc) from an accredited institution in Statistics, Mathematics, Computer Science, or related field (Psychology, Data Science, Finance, etc.), with a minimum seven (7) years of data science experience; Or
  • Master of Science (MSc) from an accredited institution in Statistics, Mathematics, Computer Science, or related field (Psychology, Data Science, Finance, etc.), with six (6) years of experience within the pharmaceutical industry, CROs, regulatory authorities or academic institutions; Or
  • Doctoral Degree (PhD) from an accredited institution in Statistics, Mathematics, Computer Science, or related field (Psychology, Data Science, Finance, etc.), with three (3) years of experience within the pharmaceutical industry, CROs, regulatory authorities or academic institutions.
  • Broad knowledge and advanced experience in understanding of clinical trial and drug development processes
  • Comprehensive knowledge of CDISC standards
  • Advanced project lead experience

Eligibility Requirements:

  • Must be legally authorized to work in the United States without restriction.
  • Must be willing to take a drug test and post-offer physical (if required).
  • Must be 18 years of age or older.
  • This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation.

Tagged as: Senior/Principal Statistical Programmer