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Statistical Lead for Clinical Trials
2 semanas atrás
We are seeking a skilled Statistical Lead to oversee multiple clinical trials and lead the development of statistical programming. The ideal candidate will have extensive experience in biotech, pharma, or CRO with at least 7 years of clinical research experience.
The successful candidate will be responsible for developing, maintaining, and validating annotated Case Report Forms (aCRFs), specifications, and statistical programming of SDTM datasets, ADaM datasets, Tables, Listings, and Figures (TLFs), and submission packages.
This role involves reviewing and providing input into Statistical Analysis Plans (SAPs), TLF Shells, and Data Management (DM) documents. You will also support data cleaning activities, utilize global SAS macros, and validate SDTMs, ADaMs, and define.XMLs with Pinnacle 21.
Key Responsibilities- Lead clinical trial teams to produce high-quality deliverables within timelines and budgets, following ICH guidelines, industry standards, regulatory requirements, and company SOPs.
- Review programming scope, budget, and out-of-scope tasks.
- Support data cleaning activities, utilizing global SAS macros for efficiency.
- Act as unblinded primary or QC programmer for randomization plans, IDMCs, and IAs.
- Strong experience with clinical trial data, SAPs, TLFs, and specifications.
- Proficiency in SAS; SAS certification preferred.
- Familiarity with CDISC standards; CDISC certification preferred.
- Deep understanding of drug development, ICH guidelines, regulations, and electronic data submissions.
- Highly organized, detail-oriented, with good project management skills.
- Permanent full-time position.
- Benefits package.
- Ongoing learning and development.
We are a global leader in dermatology and rheumatology clinical research, committed to diversity and equal opportunity.
