Jobs at Cytel

You will contribute by:

• Providing significant technical expertise for statistical programming in all phases of programming support, developing automated reports and preparation of submission data standard packages.
• Supporting statistical programming activities for multiple and/or large/complex drug/vaccine clinical development projects.
• Development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures),
• Design and maintenance of statistical datasets that support multiple stakeholder groups.
• Serving as key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables.
• Being able to serve as statistical programming point of contact and knowledge holder through the entire product lifecycle for the assigned protocol if/when called upon.
• Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices.
• Maintaining and managing a project plan including resource forecasting.
• Coordinating the activities of the supplier’s programming team; and interacting with client statistical programmers
• Utilizing strong project management skills and ability to engage key stakeholders; leadership at a protocol level; determining approach and ensuring consistency, and directing development of others when opportunities arise.
• Designing and developing complex programming algorithms.
• Comprehending analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts.
• Utilizing expertise in CDISC and ADaM standards.  
• Statistical programming for early and late stage clinical trials which can include both planned and ad-hoc needs.   
• Enriched / Post Processed Datasets (individual or integrated).
• ADaM datasets (individual or integrated)
• Protocol and therapeutic area specific tables, listings, and figures (individual or integrated).
• Programming documentation following SOPs .

What you offer:

• Bachelor’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
• Minimum 10 years of SAS programming experience supporting clinical trials in the Pharmaceutical & Biotech industry.   
• 5+ years of study lead experience working with cross functional teams, including leading programming teams.    
• Minimum 3 years of recent experience supporting Oncology studies.    
• Strong experience in QCing and validating work of other programmers, preferably outsourced work.  
• Strong SAS data manipulation, analysis and reporting skills- with strong output programming experience  
• Strong proficiency implementing the latest CDISC SDTM / ADaM standards.   
• Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.  
• Submissions experience utilizing define.xml and other submission documents.
• Excellent analytical & troubleshooting skills.
• Ability to provide quality output and deliverables, in adherence with challenging timelines.
• Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.

go to method of application »

Summary of Job Responsibilities:

The Senior Statistical Programmer leads the programming activities for a trial, early phase project, indication, or publication activities. Develops and supports statistical programming computer systems that are used in the production of statistical analysis plan (SAP)-planned tables, data listings, and graphs, integrated summaries of safety and efficacy, ad hoc analyses and electronic submission deliverables, such as datasets, data documentation, programs, programming table of contents, and patient profiles. If the programmer is delegated as a lead there may be additional responsibilities for monitoring and meeting assigned program milestones as well as leading a small team of statistical in-house or consultant programmers to accomplish tasks. 

Essential functions include creating systems that assist the Statistical Programming staff and Biostatistical staff to create tables, data listings, graphs, and analysis for final reports, abstracts, posters, manuscripts, and other clinical publications; developing systems to support  electronic regulatory submissions; providing systems and support for clinical data management staff, clinical programmers, quality control (QC) staff, and biostatisticians; producing and supporting systems that extract data from the clinical database; and building analysis databases composed of SAS datasets.

The Senior Statistical Programmer must follow established standardized design and programming procedures; provide mentoring to junior level Statistical Programmers; assist in establishing standardized programming procedures and work instructions; develop, enhance, evaluate, and validate standardized macros and utility programs; ensure that regulatory requirements are met through validation/compliance activities; and develop and maintain clinical processing work flow systems.

The Senior Statistical Programmer works on the Client's systems and under the Client's SOPs/processes.  The Functional Service Provider (FSP) programmers support various projects across the portfolio, by augmenting the Client's current staff.

Qualifications and Experience:                                                         

• Minimum Education: BS or MS degree in Computer Science, Statistics, or related health science field with a minimum of 5 years of SAS programming experience with clinical trial data.

• Minimum Work Requirements: General knowledge of regulatory requirements and drug development process.
• Skills: Excellent organizational skills and good verbal and written communication skills. Ability to work independently is required.

go to method of application »

Summary of Job Responsibilities:

The Senior Statistical Programmer leads the programming activities for a trial, early phase project, indication, or publication activities. Develops and supports statistical programming computer systems that are used in the production of statistical analysis plan (SAP)-planned tables, data listings, and graphs, integrated summaries of safety and efficacy, ad hoc analyses and electronic submission deliverables, such as datasets, data documentation, programs, programming table of contents, and patient profiles. If the programmer is delegated as a lead there may be additional responsibilities for monitoring and meeting assigned program milestones as well as leading a small team of statistical in-house or consultant programmers to accomplish tasks. 

Essential functions include creating systems that assist the Statistical Programming staff and Biostatistical staff to create tables, data listings, graphs, and analysis for final reports, abstracts, posters, manuscripts, and other clinical publications; developing systems to support  electronic regulatory submissions; providing systems and support for clinical data management staff, clinical programmers, quality control (QC) staff, and biostatisticians; producing and supporting systems that extract data from the clinical database; and building analysis databases composed of SAS datasets.

The Senior Statistical Programmer must follow established standardized design and programming procedures; provide mentoring to junior level Statistical Programmers; assist in establishing standardized programming procedures and work instructions; develop, enhance, evaluate, and validate standardized macros and utility programs; ensure that regulatory requirements are met through validation/compliance activities; and develop and maintain clinical processing work flow systems.

The Senior Statistical Programmer works on the Client's systems and under the Client's SOPs/processes.  The Functional Service Provider (FSP) programmers support various projects across the portfolio, by augmenting the Client's current staff.

Qualifications and Experience:                                                         

• Minimum Education: BS or MS degree in Computer Science, Statistics, or related health science field with a minimum of 5 years of SAS programming experience with clinical trial data.

• Minimum Work Requirements: General knowledge of regulatory requirements and drug development process.
• Skills: Excellent organizational skills and good verbal and written communication skills. Ability to work independently is required.

go to method of application »

You will contribute by:

• Providing significant technical expertise for statistical programming in all phases of programming support, developing automated reports and preparation of submission data standard packages.
• Supporting statistical programming activities for multiple and/or large/complex drug/vaccine clinical development projects.
• Development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures),
• Design and maintenance of statistical datasets that support multiple stakeholder groups.
• Serving as key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables.
• Being able to serve as statistical programming point of contact and knowledge holder through the entire product lifecycle for the assigned protocol if/when called upon.
• Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices.
• Maintaining and managing a project plan including resource forecasting.
• Coordinating the activities of the supplier’s programming team; and interacting with client statistical programmers
• Utilizing strong project management skills and ability to engage key stakeholders; leadership at a protocol level; determining approach and ensuring consistency, and directing development of others when opportunities arise.
• Designing and developing complex programming algorithms.
• Comprehending analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts.
• Utilizing expertise in CDISC and ADaM standards.  
• Statistical programming for early and late stage clinical trials which can include both planned and ad-hoc needs.   
• Enriched / Post Processed Datasets (individual or integrated).
• ADaM datasets (individual or integrated)
• Protocol and therapeutic area specific tables, listings, and figures (individual or integrated).
• Programming documentation following SOPs .

What you offer:

• Bachelor’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
• Minimum 10 years of SAS programming experience supporting clinical trials in the Pharmaceutical & Biotech industry.   
• 5+ years of study lead experience working with cross functional teams, including leading programming teams.    
• Minimum 3 years of recent experience supporting Oncology studies.    
• Strong experience in QCing and validating work of other programmers, preferably outsourced work.  
• Strong SAS data manipulation, analysis and reporting skills- with strong output programming experience  
• Strong proficiency implementing the latest CDISC SDTM / ADaM standards.   
• Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.  
• Submissions experience utilizing define.xml and other submission documents.
• Excellent analytical & troubleshooting skills.
• Ability to provide quality output and deliverables, in adherence with challenging timelines.
• Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.