Vacancies at Cytel

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.

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Summary of Job Responsibilities:

As member of the Functional Service Provider (FSP) group, and reporting to the Director / Associate Director of statistical programming, the main responsibilities of the Principal Statistical Programmer will be to:

• Provide leadership in promoting communication and adequate information flow to motivate, encourage and align people with the company's strategic objectives.
• Lead, or contribute to, statistical programming activities on FSP projects (development or QC of deliverables):
• delivering exemplary performance and solving complex technical problems to inspire other programmers,
• ensuring an efficient collaboration with BDM teams in Europe and India,
• being accountable for the quality, traceability, reproducibility and timeliness of statistical programming deliverables,
• being accountable for overall client satisfaction with these deliverables,
• maintaining a detailed project and validation plan,
• efficiently communicating with internal and external clients,
• and ensuring budget monitoring and adherence
• Ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance:
• Clinical study reporting, e.g. ICH E3
• Electronic records handling, e.g. Chapter 21 of the US Code of Federal Regulation - Part 11
• Electronic submission of clinical data to agencies, e.g. e-CTD guidance and CDISC SDTM and ADaM standards
• Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers…)
• Understand, follow and ensure adherence to, all CRS WIs/SOP as well as any other Client relevant WI/SOPs.
• Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation
• When needed, interact with regulatory agencies regarding specifications for electronic submissions, and direct/develop statistical programming electronic submission deliverables.

Occasionally, responsibilities will also include to:

• Contribute to the development of a strong team of statistical programmers, by functionally managing local programmers with respect to statistical programming strategy, deliverables, processes, and professional development
• Contribute to budget evaluation for proposal writing purpose.
• Lead, or contribute to, the design of new statistical programming processes or optimization of existing ones to reach the best productivity, to ensure the best quality of the statistical outputs, and to reach the best customer satisfaction (internally and externally) with flexibility, reliability and responsiveness.

Qualifications and Experience:

• Minimum Education: BSc or equivalent with research experience, and/or MS (in a numerate discipline preferably in Statistics, Computer Science, or Mathematics)

Minimum Work Requirements:

• Preferably at least 10 years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development
• Consistent experience as a lead statistical programmer on several concurrent projects
• Proficient in SAS
• Strong knowledge of CDISC ADaM and SDTM.
• Strong understanding of drug development, including knowledge of interfaces and interdependencies with other functions.
• Strong knowledge of relevant regulatory and data submission guidelines..
• Strong project management skills

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• Working under the direction of the Principal Programmer, the senior statistical programmer conducts programming activities for a trial, early phase project, indication, or publication activities.
• Lead at least one study team in terms of providing technical and domain-related guidance.
• May require to lead and manage a team of 2-4 members
• Ability to work on data migration from legacy datasets to standards such as CDISC or any other client-specific standard.
• Read and understand the program specifications document.
• Prepare SAS analysis datasets, tables, listings, and figures as per specifications.
• Create programs to create graphs and tables that are required in CSRs, safety reports, efficacy reports, etc. ensuring on-time quality delivery.
• Validate and transform datasets as per client assignment specifications.
• Validate tables, listings, and figures as per client assignment specifications.
• Coordinate with the client and US team for clarity of specifications, data issues, outliers, reviews, schedules, etc.
• Contribute to the organization’s recruitment process by identifying needs and required skill set of resources and conducting interviews to hire appropriate resources.
• Perform all the above tasks using standard operating procedures (SOPs) as defined in Quality Management System or the respective client(s) as applicable

Qualifications and Experience:

• Bachelors or Masters's degree in Computer Science, Statistics, or related health science field with 5 plus years of SAS programming experience with clinical trial data.
• CDISC experience is required.
• Well conversant with regulatory requirements and drug development process.
• Good understanding of the Clinical trial domain and good SAS programming skills
• Ability to work independently.