SAS / R Programming ( Real World Evidence (RWE) Statistician)
Key Duties and Responsibilities:
Responsible for all scientific and operational statistical work for assigned observational studies, real world data investigations, or clinical trials. Performs critical review of study protocols including study design and analysis methods, performs critical review of data and analysis results, conduct statistical analysis, and undertakes new and complex issues with some mentoring and guidance.
Participates in regular Study Execution Team meetings, representing Real World Statistics as a member of cross functional teams, providing strategic input and expert technical guidance to team members.
Effectively collaborates with multiple stakeholders from Health Economics and Outcome Research, Medical Affairs, Clinical Development and Real World Evidence teams.
When needed, supports development of study documents owned by Statistics such as Cross-functional Data Review plan, Key Results Memo, and Data Dissemination Plan in order to facilitate the review, summary, and dissemination of key study data/results.
When collaborating with statistical programming for deliverables, provides input into the programming specifications and perform critical review. Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with high quality.
Contributes to study reports, publications, and related processes.
Knowledge and Skills:
Demonstrated ability to design and analyze observational studies with knowledge of US healthcare system, health insurance billing data, and electronic medical record data.
Strong programming skills; familiarity with data analysis methods.
Ability to work effectively in a constantly changing, fast-paced, diverse, and matrix environment.
Ability to multitask; strong work ethic and a "can-do" mentality.
Ability to show critical thinking with logical problem-solving.
Excellent written and verbal communication skills.
Excels in a team environment.
Collaborates well with non-statisticians.
Education and Experience:
PhD or Master degree in Biostatistics or related fields with 3 to 7 years of relevant work experience.
Minimum 2 years of experience working on observational studies within the life sciences industry, government, or consulting environment. Pharma/Biotech experience highly desired.
3 years SAS and R programming experience is required.
Remote, 12-month contract with potential to extend long term
This position is to serve as a lead statistician for oncology studies, and to coordinate activities with other functional groups to ensure timely deliverables.
Responsibilities:
• Provide statistical expertise for design, analysis and reporting of clinical or pre-clinical studies
• Collaborate with various functions on study design and planning, protocol development, statistical methodology and analysis.
• Develop statistical analysis plans and analysis specifications.
• Collaborate with statistical programming to ensure that analysis is conducted per statistical plan and specifications.
• Collaborate with data management and clinical operations to ensure robust CRF and database development and quality data collection.
• Collaborate in publications, assist in data interpretation, and ensure consistency and accuracy in data presentation
• Contribute to the development of functional-level standards, SOPs, and templates.
• Represent biostatistics on study/project teams.
Education, Experience and Skills Requirement:
• Ph.D. biostatistics, epidemiology or related field, min. of 5 years of work experience as biostatistician in the biotech/pharmaceutical industry.
• Experience with Phase I & II Oncology trials experience
• Ability to work independently and within a team.
• Excellent verbal and written communication skills
• Good interpersonal and project management skills are essential.
• Proficiency in SAS and/or R.
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