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Senior Statistical Programmer FSP

Min Experience

8 years

Location

remote

JobType

Full Time

About the job

Info This job is sourced from a job board

About the role

Cytel empowers life science leaders to maximize the potential of therapies through data and software solutions. As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. 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 (ISS/ISE), utilizing SAS programming Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs) Production and QC / validation programming Generating complex ad-hoc reports utilizing raw data Applying strong understanding/experience of Efficacy analysis Creating and reviewing submission documents and eCRTs Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries Performing lead duties when called upon 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 Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have: Bachelor'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. Study lead experience, preferably juggling multiple projects simultaneously preferred. Strong SAS data manipulation, analysis and reporting skills. Solid experience implementing the latest CDISC SDTM / ADaM standards. Strong QC / validation skills. Good ad-hoc reporting skills. Proficiency in Efficacy analysis. 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. Experience supporting immunology, respiratory or oncology studies would be a plus. 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.

About the company

At Cytel, our mission is to unlock the power of data, empowering life science leaders to realise the full potential of therapies. We are committed to enhancing clinical decision-making through advanced software and data analysis tools. With a focus on innovation and excellence, Cytel partners with biopharmaceutical companies, providing them with solutions that leverage our deep understanding of statistics and trial design. Our extensive expertise allows us to support clients at every stage of the clinical development process. From preclinical to post-market studies, we aim to optimize trial outcomes and ensure success in the competitive landscape of life sciences. By leveraging our comprehensive suite of services, we help clients navigate complex regulatory environments and make informed decisions based on robust data insights.

Skills

SAS
CDISC
SDTM
Adams
Clinical Trials
Data Manipulation
Data Analysis
Reporting
QC Reviews
Validation
Ad Hoc Reporting
Define.Xml
Analytical Skills
Advanced Troubleshooting Skills
XML
Clinical Trial Data Review
ISS
QC Validation Programming
Submission Documentation