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Skills
Clinical Data Interchange Standards Consortium (CDISC)unmatched
Clinical Data Managementunmatched
Clinical Study Publicationsunmatched
Clinical Trialunmatched
Communication Skillsunmatched
Cross-Functionalunmatched
Data Setsunmatched
Drug Development Methodologiesunmatched
Immunologyunmatched
Leadershipunmatched
Medical Writingunmatched
Neuroscienceunmatched
Oncologyunmatched
Presentation/Verbal Skillsunmatched
R Programming Languageunmatched
Regulationsunmatched
Regulatory Submissionsunmatched
Standard Operating Procedures (SOP)unmatched
Standards Developmentunmatched
Statements on Auditing Standards (SAS)unmatched
Statistical Analysis System (SAS)unmatched
Statistical Programming Languagesunmatched
Statisticsunmatched
Team Lead/Managerunmatched
Team Playerunmatched
Time Managementunmatched
Writing Skillsunmatched
Description
Lead Statistical Analyst || Cincinnati , OH - Onsite || Fulltime || 10 - 25 years of experience
Job Description
Required Skillsets:
Experience in leading a team of statistical programmers for a compound/indication or therapeutic area
Proficiency in SAS / R programming languages to Program and validate ADaM , TFL and statistical analyses
In-depth understanding of SAS programming concepts and techniques in drug development process and clinical study life cycle
Good to have experience in other statistical programming languages (R).
In-depth understanding of CDISC standards and therapeutic area (Oncology, Immunology , Neuroscience Etc.)
Experience with regulatory filings.
Effective communication skills (both written and verbal)
Ability to effectively represent the Statistical Programming Organization in cross functional teams (Statisticians, Clinical Data Management, Medical Writing, Regulatory Publishing and Clinical Operations).
Ability to accurately estimate effort required for project related programming activities.
Ability to work collaboratively in a team environment and adapt to changing priorities and deadlines
Key Responsibilities:
Leads the statistical programming activities for a compound/inidication.
Leads a team of statistical programmers and manages the resource planning for assigned staff.
Ensures timely deliverables, that all quality processes are followed and consistency within the projects.
Develops and oversees the development of SAS programs for the creation of ADaM data sets following CDISC standards.
Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures.
Ensures consistency of ADaM data sets for individual studies and integrated data.
Creates documentation for regulatory filings including reviewers guides and data definition documents.
Leads the development of standard SAS Macros and participates in the development of standard operating procedures.
Provides oversight and mentoring of assigned Statistical Programmers, Statistical Analysts and Senior Statistical Analysts.
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.