CaryRecruiter Since 2001
the smart solution for Cary jobs

Principal Statistical Programmer 1

Company: Cytel Inc
Location: Morrisville
Posted on: June 11, 2021

Job Description:

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services.  At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.

 

Principal Statistical Programmer (FSP)

 

The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. In addition, the Senior Manager fluently and routinely briefs management on accomplishments, status, and issues under their own initiatives, as well as being a designated member of clinical sub-team(s) in the role of project lead Statistical Programmer.

Key Responsibilities:

  • Provides technical and project management leadership in SAS programs and applications designed to analyze and report complex clinical trial data in Tables, Listings, and Figures, and for electronic submissions of SDTM, ADaM datasets in CDlSC format, with minimal instruction or input from supervisor
  • Provides technical and project management leadership to create, review, and approve documentation required to support data analysis, reporting, and CDlSC data submission
  • Provides leadership to ensure compliance with company SOP'S and FDA/ICH/GCP regulations
  • Conducts briefings and participates in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMA, et cetera) for projects with more significant consequences and impact
  • Performs quality control checks of advanced SAS code for datasets and output produced by other Statistical Programmers
  • Performs review on define.xml and create reviewers guide for ADaM datasets
  • Review, maintain study documents per standard process
  • Program, test, and document global utility programs and tools in accordance with standards and validation procedures
  • Perform other duties as assigned

Technical and Communication Skills:

  • Experience with BLAs, MAAs and other regulatory submissions is a plus
  • Proven expert in all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
  • Displays highly evolved written and oral presentation skills that enable him/her to disseminate the importance of complex technical solutions more articulately and persuasively
  • Excellent and transparent communication skills and ability to influence across multiple functions

Preferred Education and Experiences:

  • MS in biostatistics or a related field, with 8+ years of experience in pharmaceutical industry, or BS in biostatistics or a related field, with 10+ years of experience in pharmaceutical 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.

Keywords: Cytel Inc, Cary , Principal Statistical Programmer 1, Other , Morrisville, North Carolina

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest North Carolina jobs by following @recnetNC on Twitter!

Cary RSS job feeds