MS in Statistics, Computer Science, or a related field with 9+ years of relevant experience, or BS with 11+ years of relevant experience
Minimum of 2 years' experience leading a team of statistical programmers
Proficiency in SAS and R programming languages to program and validate ADaM, Tables, Listings and Figures
In-depth understanding of CDISC standards and the drug development process, including regulatory filings
Requirements:
Leads the statistical programming activities for one or more compounds/indications or a therapeutic area
Manages a team of statistical programmers and resource planning for assigned projects
Develops and oversees SAS programs for creation of ADaM data sets following CDISC standards and for Tables, Listings and Figures
Creates documentation for regulatory filings including reviewer guides and data definition documents; develops standard SAS macros and SOPs; mentors staff
Job description
Educational Qualification / Experience for the role:
MS in Statistics, Computer Science or a related field with 9+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 11+ years of relevant experience. Minimum of 2 years' experience leading a team of statistical programmers.
Required Skillsets:
1. Experience in leading a team of statistical programmers for a compound/indication or therapeutic area
2. Proficiency in SAS / R programming languages to Program and validate ADaM , TFL and statistical analyses
3. In-depth understanding of SAS programming concepts and techniques related to drug development and clinical study life cycle.
4. In-depth understanding of CDISC Standards and therapeutic area (Oncology, Immunology , Neuroscience Etc.).
5. In-depth understanding of the drug development process, including experience with regulatory filings.
6. Ability to communicate clearly both oral and written.
7. Ability to effectively represent the Statistical Programming Organization in cross functional teams (Statisticians, Clinical Data Management, Medical Writing, Regulatory Publishing and Clinical Operations).
8. Ability to accurately estimate effort required for project related programming activities.
9. Ability to work collaboratively in a team environment and adapt to changing priorities and deadlines
Key Responsibilities:
1. Leads the statistical programming activities for one or more compounds/indications or a therapeutic area.
2. Manages a team of statistical programmers and the resource planning for their assigned projects.
3. Ensures timely deliverables, that all quality processes are followed and consistency within the projects.
4. Develops and oversees the development of SAS programs for the creation of ADaM data sets following CDISC standards.
5. Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures.
6. Ensures consistency of ADaM data sets for individual studies and integrated data.
7. Creates documentation for regulatory filings including reviewers guides and data definition documents.
8. Leads the development of standard SAS Macros and the development of standard operating procedures.
9. Manages, mentors and creates career development plans for assigned staff.
10. Participates in the recruitment and selection of new staff.
Desirable Skills:
Keyword:
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.
