OVERALL SUMMARY OF POSITION:
The Statistical Programming Director will be responsible for the organization and long-term strategic leadership of a statistical programming unit that supports multiple drug development programs The position requires a broad, comprehensive and detailed knowledge of statistical programming languages and software, filing support, clinical trial databases, and pharmaceutical drug development process.
The incumbent will manage a group of programmers who develop statistical programs that generate analysis datasets, produce outputs for tables and graphs, validate statistical programs, write general SAS application codes, prepare documentation for electronic submissions, and explore new technologies to improve productivity of statistical programming.
* Collaborates with lead project Biostatisticians in the creation, implementation, and maintenance of programming development plans for each project accounting for timelines, resources, and quality deliverables for all project work assigned; ensure that all programming has been carried out per industry and internal standard practice.
* Collaborate with Data Management to implement the CDISC standard at the CRF and database build-up stage.
* Supports overseeing the projects for the creation of analysis datasets, production/validation of output, and review of annotated case report forms
* Contributes to departmental process and standards initiatives such as CDISC.
* Oversees the work of internal and contract programmers, will provide guidance, and mentoring to programmers in statistical programming methodologies. The Director of statistical programming will be responsible for career development of junior programmers.
* Leads the selection and management of CROs (including the strategic outsourcing providers) conducting statistical programming.
* Oversee the work of staff in support of clinical trials, ad-hoc analysis requests, data validation, etc. in accordance with all relevant statistical regulatory guidance and standards.
Minimum Basic Qualifications:
* M.S.(or higher) in Statistics, Computer Science or other closely related field to programming.
* Min. 10 years clinical/statistical programming within pharmaceutical industry
Preferred Qualifications and Experience:
* Demonstrated ability to manage staff that leads projects for Statistical Programming and mentoring junior programmers
* At least 5 years of demonstrated leadership experience; career progression.
* Experience leading teams supporting NDA and EMEA filings.
* Flexible to changing priorities, detail-oriented, works well under pressure with initiative to take on unfamiliar tasks.
* Demonstrated ability to establish and articulate a plan for a team to ensure appropriate focus and direction
* Demonstrated ability to accept responsibility for individual and team performance (accountability & ownership)
* Demonstrated ability to evaluate the business impact of decisions and remains committed to following through on agreed upon decisions yet remains flexible should priorities change (judgment and decision making)
* Experience in development and implementation of statistical programming standards and procedures is required
* Experience using industry standards such as CDASH, SDTM, and ADaM.
* Excellent working knowledge of Base SAS, SAS/STAT, SAS Macro language and SAS SQL; SAS/GRAPH a plus. Experience using SAS version 8 or higher