Principal Statistical Programmer

6+ years

Not Disclosed

Remote, USA

10 Aug. 6, 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

Senior/Principal Statistical Programmer - Remote

Company: Cytel Software Corporation

At Cytel, we are dedicated to creating meaningful career growth and professional success for our employees. In turn, our team members are committed to advancing Cytel’s mission. Our environment fosters talent, experience, and integrity to push the boundaries of clinical development.

Position Overview:

As a Senior/Principal Statistical Programmer, you will use your advanced SAS programming expertise and proficiency in CDISC standards (SDTM & ADaM) to support or lead Phase I-IV clinical trials. This position is available as a fully remote role.

Our Values:

Scientific Rigor: We apply rigorous scientific methods to unlock the full potential of data.
Intellectual Curiosity: We encourage enthusiasm and a desire for discovery when facing new challenges.
Collaboration: We value diverse perspectives and talents to create a broad range of possibilities.
Innovation: We seek intelligent solutions using cutting-edge technology.

Key Responsibilities:

Perform data manipulation, analysis, and reporting for clinical trials, focusing on safety and efficacy (ISS/ISE) using SAS programming.
Generate and validate SDTM and ADaM datasets/analysis files, including tables, listings, and figures (TLFs).
Conduct production and QC/validation programming.
Create complex ad-hoc reports utilizing raw data.
Apply a strong understanding of efficacy analysis.
Develop and review submission documents and eCRTs.
Communicate with internal cross-functional teams and clients regarding project specifications, status, issues, or inquiries.
Assume lead duties when required.
Demonstrate adaptability and flexibility in response to changing priorities.

Qualifications:

Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related field.
At least 8 years of SAS programming experience with clinical trial data in the pharmaceutical or biotech industry. Alternatively, at least 6 years of related experience with a master’s degree or higher.
Preferred experience as a study lead, managing multiple projects simultaneously.
Strong skills in SAS data manipulation, analysis, and reporting.
Extensive experience with CDISC SDTM and ADaM standards.
Proficiency in QC/validation and ad-hoc reporting.
Solid understanding of efficacy analysis.
Familiarity with the drug development lifecycle and clinical trial data manipulation, analysis, and reporting.
Experience with submission documents, including define.xml, is desirable.
Experience with rare diseases and gastrointestinal studies is a plus.
Excellent analytical and troubleshooting skills.
Ability to deliver high-quality output within challenging timelines.
Effective in a globally dispersed team environment with cross-cultural partners.

Why Cytel?

Cytel is a global CRO that provides cutting-edge biostatistical software and services to major pharmaceutical and emerging biotech clients worldwide. Our patient-centric approach accelerates the development of life-saving drugs and devices.

We offer a comprehensive and competitive reward package, including world-class employee benefits and supportive policies. Our initiatives are designed to support you and your family throughout your career journey.

Equal Opportunity:

Cytel Inc. is an Equal Employment/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other protected characteristics.

Note:

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

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Principal Statistical Programmer

Job Description

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