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

Cytel

6+ 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

Senior Statistical Programmer

About Cytel:

At Cytel, we are committed to fostering successful careers and significant professional growth for our employees. Our collaborative environment blends talent, experience, and integrity to advance clinical development and drive success in the pharmaceutical industry.

Role Overview:

As a Senior Statistical Programmer, you will work under the direction of the Team Lead or Project Manager, performing programming activities for trials, early-phase projects, indications, or publication activities. This role involves leading a study team, managing data migration, and ensuring high-quality delivery of analysis datasets, tables, and reports.

Key Responsibilities:

Lead and provide technical and domain-related guidance to at least one study team; may also manage a team of 2-4 members.
Perform data migration from legacy datasets to CDISC or client-specific standards.
Read and interpret program specifications documents.
Prepare SAS analysis datasets, tables, listings, and figures according to specifications.
Develop programs to generate graphs and tables required for Clinical Study Reports (CSRs), safety reports, efficacy reports, and ensure timely delivery.
Validate and transform datasets and ensure that tables, listings, and figures meet client specifications.
Coordinate with clients and the US team to clarify specifications, address data issues, manage outliers, and adhere to schedules.
Contribute to the recruitment process by identifying resource needs, conducting interviews, and hiring appropriate candidates.
Adhere to standard operating procedures (SOPs) as defined in the Quality Management System or by respective clients.

Qualifications and Experience:

BS or MS degree in Computer Science, Statistics, or a related health science field.
Minimum of 5 years of SAS programming experience with clinical trial data.
Strong understanding of regulatory requirements and the drug development process.
Proficient SAS programming skills and a solid grasp of the clinical trial domain.
Ability to work independently and manage multiple tasks effectively.

Why Cytel?

Career Growth: We offer competitive compensation, an excellent benefits package, and opportunities for professional development.
Work Environment: Enjoy a supportive and collaborative workplace with a focus on innovation and results.
Diversity & Inclusion: Cytel is an Equal Employment / Affirmative Action Employer. We consider applicants for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity, or any other protected characteristics.

Important Notice:

Cytel does not accept referrals from employment businesses or agencies for vacancies posted on this site. All employment businesses or agencies must contact Cytel’s human resources department for prior written authorization before referring any candidates. Unauthorized referrals will not incur any liability or fees for Cytel.

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

Job Description

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