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Senior Statistical Programmer- Fsp- Permanent-Remote

5+ years
Not Disclosed
10 Aug. 16, 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, CPC Certified, 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 is a leader in biostatistics and operations research, providing unparalleled expertise to the life sciences industry through both software and services. At Cytel, we are committed to fostering significant professional growth for our employees, which in turn drives the success of our company. We are a place where talent, experience, and integrity unite to advance the field of clinical development.

Position Overview: Senior Statistical Programmer

As a Senior Statistical Programmer, you will work under the guidance of the Principal Programmer, leading programming activities for trials, early-phase projects, indications, or publication activities. Your key responsibilities will include:

  • Leading at least one study team, offering technical and domain-related guidance.
  • Potentially managing a team of 2-4 members.
  • Handling data migration from legacy datasets to standards such as CDISC or other client-specific standards.
  • Reviewing and understanding program specification documents.
  • Preparing SAS analysis datasets, tables, listings, and figures according to specifications.
  • Developing programs to create graphs and tables for Clinical Study Reports (CSRs), safety reports, and efficacy reports, ensuring timely and quality delivery.
  • Validating and transforming datasets as per client specifications.
  • Validating tables, listings, and figures as per client specifications.
  • Coordinating with clients and the US team to clarify specifications, address data issues, review schedules, and more.
  • Contributing to the recruitment process by identifying resource needs, required skill sets, and conducting interviews to hire suitable candidates.
  • Performing all tasks in accordance with standard operating procedures (SOPs) defined in the Quality Management System or by the respective client(s).

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.
  • Strong knowledge of regulatory requirements and the drug development process.
  • Solid understanding of the clinical trial domain and advanced SAS programming skills.
  • Ability to work independently.

Cytel Inc. is an Equal Employment Opportunity / Affirmative Action Employer. All applicants are considered 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.

Note: Cytel does not accept referrals from employment agencies or businesses without prior written authorization from our human resources department. Any referrals made without this authorization will not be recognized, and Cytel will not be liable for any associated fees.