Statistical Programmer - Fsp - Pune/Hyderabad(Office Based/Hybrid)

5+ years

Not Disclosed

Hyderabad Pune

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

Statistical Programmer

About Cytel:

At Cytel, we are dedicated to fostering successful careers and significant professional growth for our employees. Our commitment to talent, experience, and integrity drives our mission to advance the state of clinical development. Our collaborative environment encourages innovation and rewards results, and we pride ourselves on having one of the lowest turnover rates in the industry.

Role Overview:

Under the direction of a Senior Statistical Programmer/Team Lead, the Statistical Programmer will conduct programming activities for trials, early-phase projects, indications, or publication activities. This role involves preparing and validating SAS datasets, tables, listings, and figures, as well as contributing to data migration and compliance with CDISC or client-specific standards.

Key Responsibilities:

Read and interpret program specifications documents.
Prepare SAS analysis datasets, tables, listings, and figures according to specifications.
Develop programs to create graphs and tables required for Clinical Study Reports (CSRs), safety reports, efficacy reports, and ensure timely and high-quality delivery.
Validate and transform datasets and ensure tables, listings, and figures meet client specifications.
Manage data migration from legacy datasets to standards such as CDISC or other client-specific standards.
Coordinate with clients and internal teams for clarity on specifications, data issues, outliers, reviews, and schedules.
Adhere to standard operating procedures (SOPs) as defined in the Quality Management System or by the respective client(s).
Provide biostatistical support including writing SAP, offering statistical input to specifications/study documents, and reviewing study documents from a statistical perspective.

Qualifications and Experience:

Master’s degree in a relevant field with a minimum of 5 years of SAS programming experience with clinical trial data.
General knowledge of regulatory requirements and the drug development process.
Solid understanding of the clinical trial domain and proficient SAS programming skills.
Ability to work independently and effectively manage tasks.

Why Join Us?

Career Growth: Cytel offers competitive compensation, an excellent benefits package, and annual bonus incentives.
Work-Life Balance: We promote a healthy work-life balance and provide opportunities for career advancement.
Expertise: Work with respected experts and thought leaders in the field.
Diversity & Inclusion: Cytel is an Equal Employment / Affirmative Action Employer, considering applicants without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity, or any other protected characteristics.

Important Note:

Cytel does not accept referrals from employment businesses and/or agencies regarding 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. Unauthorized referrals will not incur any liability or fees for Cytel.

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Statistical Programmer - Fsp - Pune/Hyderabad(Office Based/Hybrid)

Job Description

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