1266-Principal Statistical Programmer

Employer:       Cytel, Inc. 

Position:         Principal Statistical Programmer

Location:        2200 Renaissance Blvd., Suite 370, King of Prussia, PA 19406

Duties: Draw on experience with SAS programming (BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS) to create datasets, tables, listings, graphs and figures in a variety of deliverables such as clinical study report, regulatory briefing document, abstracts, posters and manuscripts. Use Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM) standards and Enriched/Post Processed Datasets (individual or integrated) to interact with regulatory agencies regarding specifications for electronic submissions and to convert the data to a more standardized, predefined collection of domains for clinical data submission. Create Pinnacle 21 reports to validate the CDISC/SDTM/ADaM datasets. Understand regulatory requirements concerning industry technical standards (CDISC, 21 CFR (Code of Federal Regulations) Part 11, electronic submissions, etc.) and implications for the department. Create and maintain specifications as per the latest CDISC Study Data Tabulation Model Implementation Guide (SDTMIG). Develop global tools or product-wide utilities that increase the efficiency and capacity of the statistical reporting. Assist the team with electronic FDA submissions. Provide insights on the advanced study design such as New Drug Application (NDA)/Biologics License Application (BLA), Electronic Common Technical Document (eCTDs) or other global regulatory submissions. Advise on new technologies and industry technical standards (Electronic Common Technical Document, Statistical principles, CFR Part 11, electronic submissions, applications and communications technologies) and their integration into programming processes. Prepare the statistical programming plan (SAP), prepare the project tracker and assign tasks to the team. Generate Define.xml files (an XML file that has the metadata of all the datasets, their descriptions and links to the actual datasets). Support Integrated Summary of Safety or Integrated Summary of Efficacy datasets. May telecommute from any continental U.S. location.

Requirements: Master’s degree (or foreign equivalent) in Statistics, Computer Science or health-related discipline such as Chemistry, Pharmacy, Biology plus 4 year of experience reflecting demonstrable ability in the job duties described above. Alternatively, we will accept a Bachelor’s degree (or foreign equivalent) in Statistics, Computer Science or health-related discipline such as Chemistry, Pharmacy, Biology plus 6 year of experience reflecting demonstrable ability in the job duties described above.

Contact: Email resume to careers@cytel.com &  ref. Job # 8004. No calls/agents/visa sponsorship.

***This position is eligible for our Employee Referral Program.***

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.

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