Senior Statistical Programmer - Fsp (Hybrid)

4-5 years

Not Disclosed

Remote, USA

10 Aug. 6, 2024

Job Description

Job Type: Full Time Remote 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

Job Summary: Senior Statistical Programmer

Responsibilities:

Under the direction of the Team Lead or Project Manager, perform programming activities for clinical trials, early-phase projects, indications, or publication efforts.
Provide technical and domain-related guidance, leading at least one study team and potentially managing a team of 2-4 members.
Proficiently work with SDTM (Study Data Tabulation Model) datasets and handle data migration from legacy systems to CDISC or other client-specific standards.
Read and understand program specifications documents to ensure accurate and timely delivery of analysis datasets, tables, listings, and figures.
Develop programs to create graphs and tables required for Clinical Study Reports (CSRs), safety reports, efficacy reports, etc., ensuring high-quality delivery.
Validate and transform datasets according to client specifications and ensure accuracy in tables, listings, and figures.
Coordinate with clients and U.S. teams to clarify specifications, resolve data issues, address outliers, and manage reviews and schedules.
Contribute to the recruitment process by identifying resource needs, defining required skill sets, and conducting interviews to hire suitable candidates.
Adhere to standard operating procedures (SOPs) as defined in the Quality Management System or specific client requirements.

Qualifications and Experience:

Bachelor’s or Master’s degree in Computer Science, Statistics, or a related health science field.
Minimum of 5 years of SAS programming experience with clinical trial data.
Strong knowledge of regulatory requirements and the drug development process.
In-depth understanding of the clinical trial domain and excellent SAS programming skills.
Ability to work independently and manage tasks effectively.

Equal Opportunity Statement:

Cytel Inc. is an Equal Employment/Affirmative Action Employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristic 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 must contact Cytel’s human resources department to obtain prior written authorization before referring any candidates. Any actions undertaken without such authorization will be considered as performed without Cytel's consent, and Cytel will not be liable for any fees arising from such actions or referrals.

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Senior Statistical Programmer - Fsp (Hybrid)

Job Description

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