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Posted: Monday, January 8, 2018 12:50 AM

Head of Statistical Programming

The newly created role of Head of Statistical Programming 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.

Specific responsibilities will include:

* Collaborating 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; ensuring that all programming has been carried out per industry and internal standard practice).

* Collaborating with Data Management to implement the CDISC standard at the CRF and database build-up stage.

* Supporting and overseeing projects for the creation of analysis datasets, production/validation of output, and review of annotated case report forms.

* Contributing to departmental process and standards initiatives such as CDISC.

* Overseeing the work of internal and contract programmers, providing guidance, and mentoring to programmers in statistical programming methodologies.

* Career development of junior programmers and staff.

* Leading the selection and management of CROs (including the strategic outsourcing providers) conducting statistical programming.

* Overseeing 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.

Qualifications:

* Master's degree (or higher) in Statistics, Computer Science or other closely related field to programming.

* Minimum of 12+ years clinical/statistical programming within pharmaceutical industry.

* At least 5 years of demonstrated leadership experience and career progression.

* 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. (SAS version 8 or higher)

* Proficient in developing own code as well as modifying existing code.

* Demonstrated ability to manage staff that leads projects for Statistical Programming and mentoring junior programmers.

* 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 business impact of decisions, follow through on agreed upon decisions, and remain flexible when needed.

* Excellent analytical, problem solving and organization skills with the ability to work on multiple tasks.

* Excellent written and oral communication skills.

SDL2017


Associated topics: biostatistics, data analyst, probability, statistics, c

Source: http://www.jobs2careers.com/click.php?id=4641409409.96


• Location: Bothell, Seattle

• Post ID: 60908922 seattle
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