Principal Statistical Programmer
Proclinical is currently recruiting for a Principal Statistical Programmer for a biopharmaceutical company located in Gaithersburg, MD. Successful candidate will be responsible for programming clinical trial analysis deliverables with quality and timeliness, with a hands-on and collaborative approach with other team members.
- Review a clinical study protocol with regard to statistical programming responsibilities.
- Review and provide input to a Statistical Analysis Plan (SAP) and Statistical Programming Plan (SPP).
- Review and provide input to Case Report Forms (CRFs) and external data transfer agreements.
- Work cooperatively with and hold accountable clinical study team members including but not limited to the biostatistician, data manager, and medical writer.
- Work cooperatively with and oversee a contract programming provider.
- Assign tasks, set priorities, and provide technical help to clinical study programming teams.
- Develop and maintain SDTM and ADaM specifications.
- Program SDTMs, ADaMs, tables, figures, and listings (TFLs) according to approved specifications.
- Understand and enforce compliance with MedImmune programming standards and data standards in clinical study programming teams.
- Provide accurate programming time estimates and risk mitigation plans to management or a study team.
- Proactively inform management of the status of statistical programming deliverables and issues.
- Oversee on-time delivery from clinical study programming teams and meet timelines for multiple concurrent studies.
- Contribute to or initiate standards or process improvements.
Skills and Requirements:
- Bachelor's Degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field.
- 5+ years of SAS programming in clinical studies including leading a clinical study programming team.
- Excellent SAS programming skills; contribute programming to a global library of macros.
- Able to communicate clearly in oral or written form.
- Advanced knowledge of CDISC standards and applying standards to complicated data.
- Advanced knowledge of lab data processing and able to resolve issues.
- Working knowledge of medical terms, the data coding process, and coding dictionaries.
- Apply regulatory agency guidance in statistical programming responsibilities.
- Able to program in other languages (e.g. R or S-PLUS, VBA, or Perl).
- Advanced knowledge of Unix commands; able to program shell scripts for complicated tasks.
- Advanced knowledge of inferential statistics.
- Able to independently perform technical work and oversee a clinical study programming team.
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 Junis Citozi at (+1) 2 929-388-1650 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.
Swiss Franc0.00 - Swiss Franc160000.00 per annum
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