Job Description

LCC Senior Programmer



Join Cytel's enthusiastic and collaborative Biometrics team by contributing to the overall success of one of our major pharma clients. 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 experiencing exponential growth on a global scale and hiring Senior Statistical Programmers to join our FSP division. You will apply your know-how in CDISC standards (SDTM & ADaM) and advanced SAS programming skills, to support or lead one or more Phase I-IV clinical trials, across a variety of therapeutic areas. This role can be performed as fully remote.

Our values



We believe in applying scientific rigor to reveal the full promise inherent in data.



We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery.



We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.



We prize innovation and seek intelligent solutions using leading-edge technology.

How you will contribute:



• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming
• Generating and validating analysis datasets/analysis files, and complex tables, listings, and figures ( TLFs)
• Production and QC / validation programming
• Generating complex ad-hoc reports utilizing raw data and analysis datasets
• Applying strong understanding/experience of Safety and Efficacy analysis
• Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
• Performing lead duties for assigned clinical study under principle programmers oversight
• Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
• Being adaptable and flexible when priorities change
• Being able to create specifications for derived/analysis datasets
• Generating and validating Non-CDISC transformation datasets and analysis datasets
• Proficient knowledge with SDTM/ADaM and TLF's. General expertise with Figures
• Individuals should be able to start programs from scratch and have the ability to handle complicated domains and outputs related to the protocol and SAP.
• Creating and reviewing submission documents and eCRTs
• They must demonstrate a good understanding of the endpoints and data collection, with the ability to read and write specifications related to the respective implementation guides.
• R & complex macro writing are a plus

What you offer:



• Bachelor's or master's degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
• At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree or equivalent. At least 6 years of related experience with a master's degree or above.
• Familiarity with drug development life cycle and experience with the analysis and reporting of clinical trials' data.
• Familiarity with ICH E3 (Structure and Content of CSR) and E9 (Stat Principles).
• Well conversant with regulatory requirements and drug development process.
• Study lead experience, preferably juggling multiple projects simultaneously.
• Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH
• Strong CDISC (both SDTM and and ADaM) experience is required.
• Solid ADaM and complex TFL skills.
• Strong QC / validation skills.
• Good ad-hoc reporting skills.
• Experience in pooling/ ISS/SE studies is an asset.
• Experience with cross-over studies is a plus.
• Submissions experience utilizing define.xml, creation of annotated CRF, data reviewer's guides and other submission documents.
• Excellent analytical & troubleshooting skills.
• Being flexible to adapt and use client's macro codes.
• R programming knowledge for data manipulation and graphs is an asset.
• 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.
• Applied experience in one of the following therapeutic area is a plus: oncology, rare diseases, gastroenterology, respiratory, immunology, hepatitis and vaccines.
• Experience in medical affairs is a plus.