Senior Statistical Programmer – Oncology Studies at Cytel
Title: 1268 – Senior Statistical Programmer – Oncology Studies (Remote, US)
Join us in playing an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes!
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 seeking a remote Senior Statistical Programmer for our growing FSP division.
As a seasoned Statistical Programmer, with a solid background supporting Oncology studies, you will apply your strong SAS programming skills and proficiency in CDISC standards (ADaM & SDTM) to support one or more Phase I-IV clinical trials. You will report to the Director, Biostatistics & Statistical Programming.
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.
- 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.
- effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices.
- utilizing expertise in CDISC and ADaM standards.
- statistical (SAS) 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 we are looking for:
- Bachelor’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
- 8+ years of SAS programming experience in the Pharmaceutical & Biotech industry. Experience in R a plus.
- 2 years study lead experience, serving as statistical programming point of contact for the overall study, with experience leading programming teams highly desired.
- 3+ years of recent Oncology experience, including ISS/ISE required.
- Strong SDTM / ADaM skills
- Strong SAS data manipulation, analysis and reporting skills
- Strong Efficacy analysis experience
- Experience with entimICE a plus.
- 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.
What’s in it for you:
- You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development
- You will be part of an exciting new chapter in Cytel’s history with high growth and opportunities to progress in Senior and Leadership positions within the company
- Work in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementation
- Work with and leverage the best and brightest minds in the industry
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.
Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.
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