Cytel · 2 days ago
Principal Statistical Programmer
United States
Full-time
Remote
Senior Level
7+ years exp
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Responsibilities
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.
Qualification
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Required
Bachelor’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
7-8 years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development with good knowledge of CDISC ADaM and SDTM, ICH Statistical and Clinical Report Guidelines.
Study lead experience working with cross functional teams, including leading programming teams.
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.
Benefits
Competitive compensation
Excellent benefit’s package
Annual bonus incentive
Promote work-life balance
Opportunity to grow with us
Company
Cytel
Our mission is to improve success rates in this endeavor via the optimal design, effective implementation
1,001-5,000 employees
H1B Sponsorship
Cytel has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (30)
2022 (48)
2021 (38)
2020 (36)
Funding
Current Stage
Late StageTotal Funding
$2MKey Investors
New Mountain CapitalMerck Capital Ventures
2021-01-01Series Unknown· undefined
2020-12-21Acquired· undefined
2017-11-01Private Equity· undefined
Leadership Team
Cyrus Mehta
Co-Founder & President
Nitin Patel
Chairman and Chief Technology Officer
Recent News
Company data provided by crunchbase
