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    Principal Statistical Programmer

    Cytel
    5-10 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

    Principal Statistical Programmer - Remote

    Company: Cytel Software Corporation

    Cytel is at the forefront of drug development as the world’s largest independent clinical biostatistics research and development organization. We partner with leading pharmaceutical, biotech, and medical device companies to enhance clinical success rates through optimal study design, effective data management, precise statistical analysis, and innovative software solutions. With a global presence across North America, Europe, and India, we are on the lookout for passionate and talented professionals dedicated to advancing the development of safe and effective medicines.

    We are currently experiencing significant global growth and are hiring a Principal Statistical Programmer for our Functional Service Provider (FSP) division. In this role, you will utilize your strong communication and leadership skills to support or lead clinical trials across various therapeutic areas. You will report to the Associate Director of Statistical Programming.

    Responsibilities:

    • Provide expert technical support for statistical programming in all phases, including developing automated reports and preparing submission data standard packages.
    • Support statistical programming activities for large or complex drug/vaccine clinical development projects.
    • Develop and execute statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets, tables, listings, figures).
    • Design and maintain statistical datasets that support multiple stakeholders.
    • Collaborate closely with statistics and other project stakeholders to ensure efficient execution of project plans and high-quality deliverables.
    • Act as the statistical programming point of contact and knowledge holder throughout the product lifecycle for assigned protocols.
    • Perform analysis and report programming development and validation following global and therapeutic area standards, departmental SOPs, and good programming practices.
    • Manage project plans, including resource forecasting, and coordinate with the supplier’s programming team.
    • Utilize strong project management skills to engage key stakeholders, lead at a protocol level, determine approaches, and direct the development of team members.
    • Design and develop complex programming algorithms and comprehend analysis plans with statistical terminology and concepts.
    • Implement and utilize CDISC and ADaM standards effectively.
    • Perform statistical programming for early and late-stage clinical trials, including both planned and ad-hoc needs.

    Qualifications:

    • Bachelor’s degree or equivalent in a scientific discipline such as Statistics, Computer Science, or Mathematics.
    • At least 10 years of SAS programming experience supporting clinical trials in the pharmaceutical or biotech industry.
    • Over 5 years of study lead experience with cross-functional teams, including leading programming teams.
    • Minimum of 3 years of recent experience supporting oncology studies.
    • Strong experience in QCing and validating the work of other programmers, including outsourced work.
    • Proficiency in SAS data manipulation, analysis, and reporting, with a focus on output programming.
    • Expertise in implementing the latest CDISC SDTM and ADaM standards.
    • Familiarity with the drug development lifecycle and clinical trial data manipulation, analysis, and reporting.
    • Experience with submission documents, including define.xml.
    • Excellent analytical and troubleshooting skills.
    • Ability to deliver high-quality output within challenging timelines and work effectively in a globally dispersed team environment.

    Why Cytel?

    At Cytel, our collaborative work environment fosters innovation and rewards excellence, contributing to one of the lowest turnover rates in the industry. We offer a competitive compensation package, excellent benefits, an annual bonus incentive, and opportunities for career growth. Work alongside respected experts and thought leaders in biostatistics and statistical programming.

    Equal Opportunity Statement:

    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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