Principal Statistical Programmer

Company: Cytel Software Corporation
Location: Lorain
Posted on: June 12, 2022

Job Description:

Join us in playing an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes! Cytel provides unrivalled biostatistics and operations research to improve drug development success rates, crucial for human welfare. Focused on using innovative applications of statistical science and adaptive clinical trial design, Cytel is at the cutting edge of technology and human ingenuity, driving healthcare forward. We are hiring a remote Principal Statistical Programmer to work with a pharma company's internal team leading development programs in Alzheimer's Disease, Parkinson's Disease and/or ALS projects and utilize your CDISC knowledge and advanced statistical programming capabilities. This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. The Lead Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. We are looking for a highly experienced principal statistical programmer who will lead Biometrics work on clinical development programs in Alzheimer's Disease, Parkinson's Disease and/or ALS. and oversee CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner. This individual will be responsible for planning, designing, overseeing, and implementing all reporting and analysis activities for the Sponsor clinical trials We are looking for a highly experienced data analyst who will lead all statistical programming activities and oversee CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner. This individual will be responsible for planning, designing, overseeing, and implementing all reporting and analysis activities for Sponsor clinical trials. Responsibilities

• 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
• Oversee 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.
• Assist in the development of relevant procedures and processes to ensure that statistical programs are properly documented and validated according to generally recognized industry and regulatory standards
• 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
• May oversee statistical programming contractors and mentor junior team members Requirements
  • At a minimum bachelor's degree in computer science, data science, mathematics, or statistics major preferred.
  • 8+ 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),
    • experience with Amazon Web Services and cloud infrastructure, and experience with applying machine learning techniques.

Keywords: Cytel Software Corporation, Lorain , Principal Statistical Programmer, IT / Software / Systems , Lorain, Ohio