Clinical Outcomes Solutions

Principal Statistical Programmer – FSP

Clinical Outcomes Solutions

full-time

Posted on:

Location Type: Remote

Location: India

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Job Level

Lead

Tech Stack

JavaLinuxPythonUnix

About the role

  • Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
  • Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs
  • Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs’ needs
  • Participate in overseeing CRO’s statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines
  • Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
  • Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
  • Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
  • Participate in the development of CRFs, edit check specifications, and data validation plans
  • Provide review and/or author data transfer specifications for external vendor data
  • Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
  • Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices

Requirements

  • At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred
  • 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies
  • Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment
  • Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation
  • Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities
  • Must be able to work independently
  • Outstanding communication skills (written and verbal) and strong leadership skills.
  • Preferred Qualifications (nice to have)
  • Prior work experience with pharmacokinetic data and the neuroscience field,
  • proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)
Benefits
  • Commitment to developing staff
  • Development and support
  • Driven by autonomy and ownership
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
SASRPythonJavaShinyMarkdownUnix/LinuxCDISC standardsstatistical programmingdata validation
Soft Skills
communication skillsleadership skillsindependencecollaborationattention to detailproblem-solvingtime managementorganizational skillsadaptabilitycritical thinking