Principal Statistical Programmer

Company: Cytel Inc
Location: South Bend
Posted on: June 9, 2021

Job Description:

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services.  At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.

The Senior Statistical Programmer has the following resonsibilities:

• Lead programmer and primary point of contact for a clinical trial protocol. 
• Provides significant technical expertise for statistical programming, development of automated reports and preparation of submission data standard packages. 
• Participates in all phases of programming support.
• Supports statistical programming activities for multiple and/or large/complex drug/vaccine clinical development projects.  
• Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures).
• Responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups.
• Key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables.
• May serve as the statistical programming point of contact and knowledge holder through the entire product lifecycle for the assigned protocol. 
• Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices.
• Maintain and manage a project plan including resource forecasting.  
• Coordinate the activities of the supplier’s programming team; interacts with Merck statistical programmers.
• Strong project management skills; leadership at a protocol level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders.
• Designs and develops complex programming algorithms.
• Ability to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts.
• Expertise in CDISC and ADaM standards.

Qualifications & Experience:

• Master's degree, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
• 7+ years of SAS programming experience in the Pharmaceutical & Biotech industry.
• Strong SAS data manipulation, analysis and reporting skills- with strong output programming experience
• Very good experience in writing and reviewing programming specifications
• 2 years of study lead experience, preferably juggling multiple projects simultaneously strongly desired
• Ability to implement the latest CDISC SDTM / ADaM standards
• Strong ADaM experience, which includes pooling of datasets for ISS
• Totally familiar with Define.xml and reviewers guide (ADRG)
• Strong Knowledge of statistics
• Very good knowledge on e-submission preparation is strongly preferred
• Ability to provide solutions for complex programming issues (includig creation of complex macros), presenting alternatives and identifying best solution.
• R-programming experience is preferred.

Keywords: Cytel Inc, South Bend , Principal Statistical Programmer, Other , South Bend, Indiana