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Senior Statistical Programmer- Fsp- Permanent-Remote

5+ years
Not Disclosed
10 June 28, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Overview: Cytel Software Corporation

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, which results in our employees working hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.

Job Description: Senior Statistical Programmer

Responsibilities:

  • Work under the direction of the Principal Programmer.
  • Conduct programming activities for a trial, early phase project, indication, or publication activities.
  • Lead at least one study team, providing technical and domain-related guidance.
  • May require leading and managing a team of 2-4 members.
  • Perform data migration from legacy datasets to standards such as CDISC or any other client-specific standard.
  • Read and understand program specifications documents.
  • Prepare SAS analysis datasets, tables, listings, and figures as per specifications.
  • Create programs to generate graphs and tables required in CSRs, safety reports, efficacy reports, etc., ensuring on-time quality delivery.
  • Validate and transform datasets as per client assignment specifications.
  • Validate tables, listings, and figures as per client assignment specifications.
  • Coordinate with the client and US team for clarity on specifications, data issues, outliers, reviews, schedules, etc.
  • Contribute to the organization’s recruitment process by identifying needs, determining the required skill set of resources, and conducting interviews to hire appropriate resources.
  • Perform all tasks using standard operating procedures (SOPs) as defined in the Quality Management System or the respective client(s) as applicable.

Qualifications and Experience:

  • Bachelor's or Master's degree in Computer Science, Statistics, or a related health science field.
  • 5+ years of SAS programming experience with clinical trial data.
  • CDISC experience is required.
  • Well-versed in regulatory requirements and the drug development process.
  • Good understanding of the clinical trial domain and strong SAS programming skills.
  • Ability to work independently.

Additional Information:

  • 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 for 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, 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.