Senior Statistical Programmer
Proclinical is currently recruiting for a Senior Statistical Programmer with a leading pharmaceutical company located in Raleigh, NC. Successful candidate will lead and support statistical programming activities for assigned clinical studies, submissions and development initiatives.
- Provides a high level of effective collaboration for statistical programming initiatives with key team members within SSI and groups outside of SSI (Clinical Data Operations, Technology and Standards (CDOTS), Global Medical Writing, New Medicines, Global Clinical Project Management, therapy areas, Quantitative Clinical Pharmacology, Marketing & Market Access and Global Clinical Development & Medical Affairs) to facilitate understanding of statistical programming services and work product.
- May program, validate, maintain, and document statistical analysis programs for asset development on the basis of the SAP and of other documents (Protocol, CRF, DMM, ISAP, DAP and ASD) following UCB standard operating procedures and working documents.
- Where applicable, develops innovative programming methodologies (i.e. interactive visualization, dashboards, etc.) to facilitate easier interpretation by customer base
- Ensures that submission and study datasets (SDTM and ADaM), tables, figures, listings, statistical output, and program documentation meet standards requirements of regulatory agencies and other departments within UCB.
- Ensures that datasets, tables, figures, listings, and statistical outputs are produced in an efficient manner, following SSI procedures and standards. Develops specification documentation for datasets (SDTM and ADaM), pooled datasets, tables, figures, listings, and associated metadata.
- Supports direction, motivation, and oversight of statistical programming resources (internal and external) for timely delivery of all statistical programming outputs. Mentors and trains other statistical programmers as needed.
- Ensures compliance with the 21-CFR Part 11 regulations in terms of validation of SAS programs used for statistical reporting of clinical studies.
Skills and Responsibilities:
- 3+ (with Master's degree) to 7+ (with Bachelor's degree) years in statistical programming within the Biotechnology and/or Pharmaceutical Industry (including clinical research organizations) with proven successful track record in pharmaceutical development.
- Excellent understanding and profound knowledge of statistical programming aspects required for regulatory submissions.
- Expert SAS Software Programming skills, including experience with advanced DATA step, SQL and macro development to solve complex programming tasks and/or expert in other programming languages like R, or Python. Experience in Data Visualization would also be advantageous.
- Advanced clinical studies design and analysis experience.
- Advanced knowledge of statistical principles.
- Good leadership abilities and interpersonal skills to mentor and lead statistical programmers to successfully deliver high quality project, study team statistical programming work product and oversee CRO statistical programming teams.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Felix Hook at (+1) 646-367-2617 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.