Sr. Biostatistician(2 positions telecommuting, 4 on site)
• Work closely with clinicians, programmers, and publication managers to generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies; coordinate internal resource utilization for publication and generate activities metrics for management review.
• Work with the clinical study team on study design, development and/or review of clinical study protocols.
• Develop and/or review statistical analysis plans, including Table/listing/figure shells, and final study report for clinical studies; perform post-hoc statistical analyses as needed.
• Work with the project statistician and clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality.
• Oversee CRO programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, ensure the quality of CRO deliverables.
• May work with the Health Outcome team on the design/analysis/validation of projects.
• May work on submission teams as a statistician and/or a programmer.
• Must have a MS in Biostatistics/Statistics with at least 5 years of experience or a PhD in Biostatistics/ Statistics with at least 3 years of experience in the pharmaceutical, CRO or biotech industry.
• Strong SAS programming skills.
• Oncology experience is highly preferred.
• Good technical writing skills.
• Good communication skills (verbal and written).
• Strong teamwork ability/commitment and individual initiative.
• Strong organizational skills with ability to effectively manage multiple projects.
we need is an experienced statistician who can do SAS programming at the same time can clearly interprete statistical concept and results to non-statisticians and key medical opinion leaders.
Sr. Statistical Programmer (5 remote, 3 onsite)
This role is responsible for programming clinical trial analysis deliverables with quality and timeliness, with a hands-on and collaborative approach with other team members. This position requires high degree of independence, technical skills and ability to influence the team to get results without line management authority.
• 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 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
• 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
Education: Degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field.
Experience: A minimum 5 years of SAS programming in clinical studies including leading a clinical study programming team
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