2000 Regency Pkwy Suite 500 Cary, NC 27518 US
This position contributes to the Company’s success by providing statistical services in support of due diligence and leading data analysis for on-going studies to enable in-house interpretation and decision making. The incumbent responds to FDA/EMA statisticians on data questions, leading the Company’s position on data interpretation.
SUMMARY OF KEY RESPONSIBILITIES
• Writes statistical analysis programs for assigned clinical development programs or trails to generate or validate analysis data sets and tables, figures, etc. for statistical reports.
• Provides input in the development of study protocols; writes the statistical section of study protocols; develops statistical analysis plans and analysis specifications for the programming implementation of statistical analyses.
• Determines resource needs and schedules in coordination with the VP, Clinical Development & Operations, on project status, budget, and changes in scope.
• Provides statistical input for data management and programming deliverables (e.g., data collection tools, analysis datasets) to ensure they support the protocol specified goals and statistical analyses.
• Develops statistical programs, as needed, in support of ad hoc requests, manuscripts, and presentations, and provides statistical review of scientific reports and publications.
• Collaborates and writes statistical sections of regulatory documents.
• Collaborates with other functional areas on project deliverables and timelines within area of responsibility.
• Provides oversight of CRO deliverables within area of responsibility to ensure quality and accuracy.
• Adheres to the Company and departmental SOPs and working practices.
• Acts in accordance with Company policies, including, but not limited to its Code of Conduct, ensuring that policies are understood and followed.
• Other duties, as assigned.
REQUIRED QUALIFICATIONS AND SKILLS
• Biostatistician Level Requirements: MA in Statistics or Biostatistics, with a minimum of 4 years’ experience. PhD in Statistics or Biostatistics, with a minimum of 2 years’ statistical experience in the pharmaceutical or biotech industry, preferred. An equivalent combination of education and experience will be considered.
• Sr. Biostatistician Level Requirements: MA in Statistics or Biostatistics, with a minimum of 6 years’ experience in the pharmaceutical or biotech industry; PhD in Statistics or Biostatistics with a minimum of 3 years’ statistical experience in the pharmaceutical or biotech industry. PhD in Statistics or Biostatistics, with a minimum of 3 years’ statistical experience in the pharmaceutical or biotech industry, preferred.
• Current knowledge of statistical methodologies related to areas such as clinical trial design, statistical modeling, and analysis.
• Knowledge of applicable FDA regulations and ICH guidelines.
• Advanced knowledge of SAS programming language; knowledge of R, or similar language, a plus.
• Knowledge of CDISC standards, including ADaM requirements.
• Experience in Transplantation, Immunology, and related therapeutic areas, preferred.
• Experience in CRO management.
• Strong organizational and time management skills, with the ability to prioritize multiple deliverables and ad hoc requests.
• Strong oral and written communication skills.
• Strong interpersonal skills, with the ability to build credibility and trust with internal and external stakeholders.
Pay Rate Range: $80-$150/hr. Salary will be commensurate with experience
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