Contracting Senior Biostatistician II

Company Name:
Clindata Insight Inc
This position is responsible for developing, coordinating, and providing biostatistical support for clinical development programs.
Serves as statistical representative in the cross-functional teams for the clinical trial planning, executing, and reporting;
Guides the Biometrics team members in all planning activities;
Contributes to the development of Protocol by participating in study design meetings, determining appropriate statistical methodology for data analysis (including definition of endpoints, sample size planning and power calculation, specifications of statistical models and testing procedures, etc.), and drafting the statistical sections of Protocol;
Drafts data analysis plan documents such as Statistical Analysis Plan and Centralized Monitoring Plan, incorporates comments from other relevant functions, and finalizes the documents;
Specifies an appropriate randomization scheme and reviews pseudo randomization schedule(s);
Generates mock-up tables, listings, figures (TLFs) for project deliverables as necessary and incorporates comments from other relevant functions to ensure appropriate presentation of analysis results;
Reviews the SDTM specification document and generates detailed ADaM specification document based on the SDTM specification document;
Guides Statistical Programming in preparing for the project deliverables, reviews statistical outputs, and participates in validation of statistical outputs as necessary;
Prepares oral and written reports to effectively communicate outcomes of clinical trials to the study team, management, regulatory agencies, key opinion leaders, or individual investigators;
Conducts statistical quality control to ensure the accuracy of analysis results in regulatory documents or publications to be presented in public;
Provides statistical support as needed by other clinical development functions;
Participates in study team meetings and other activities organized to improve operational and statistical analysis procedures;
Other duties may be assigned as needed.
Ph.D. in Statistics or Biostatistics and 5+ years of Pharmaceutical industry or related experience preferred or MS in Statistics or Biostatistics and 8+ years of pharmaceutical industry or related experience required; ophthalmic pharmaceutical industry experience preferred;
Good knowledge of FDA statistical guidelines;
Solid understanding of mathematical and statistical principles;
Demonstrated proficiency in SAS programming (knowledge of other statistical software is a plus);
Excellent communication skills, with the ability to interpret statistical outputs with non-statisticians;
Good organizational and problem-solving skills;
Must work effectively in a team environment, independently or collaboratively

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