Senior Statistical Programmer
hace 1 mes
We are seeking a highly skilled Senior Statistical Programmer to lead our clinical trials team. As a key member of our team, you will be responsible for developing, maintaining, and validating annotated Case Report Forms (aCRFs), as well as specifications and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets, and Tables, Listings, and Figures (TLFs).
Key Responsibilities- Lead single and/or multiple clinical trials, ensuring timely delivery of high-quality deliverables.
- Develop, maintain, and validate aCRFs, SDTM specifications, ADaM specifications, and TLFs, in accordance with CDISC standards and guidelines.
- Review and provide input into Statistical Analysis Plans (SAPs), TLF Shells, and Data Management (DM) documents.
- Collaborate with Biostatistical study teams and departments to produce deliverables of the highest quality, within agreed timelines and budget.
- Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21.
- Use global SAS macros to increase efficiency of statistical programming.
- Act as Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and IAs.
- Contribute to the identification of future internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables.
- At least 7 years of clinical research experience in biotechnology, pharmaceutical, or Contract Research Organization (CRO) industry, including 5 years of Statistical Programming and 2 years acting as a Lead Statistical Programmer.
- Excellent exposure to clinical trial data, SAP, TLF Shells, and specifications.
- Excellent working knowledge of SAS, CDISC standards, and guidelines.
- Knowledge of XML programming and Pharmaceutical Industry GPP.
- Very organized and detail-oriented, with effective project planning and time management skills.
- Ability to work in high-speed environment with proven agility to juggle and prioritize multiple competitive demands.
- Strong verbal and written communication skills in English.
Innovaderm Research is a contract research organization (CRO) specialized in dermatology. We offer a stimulating work environment and attractive advancement opportunities. Our values are collaboration, innovation, reliability, and responsiveness. We are committed to providing equitable treatment and equal opportunity to all individuals. As such, we will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
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