Associate Statistical Programming Director

Associate Statistical Programming Director page is loaded## Associate Statistical Programming Director locations:
Alameda, CA:
Alameda HQtime type:
Full time posted on:
Posted Todayjob requisition :
JR6478
** SUMMARY/

JOB PURPOSE:

** Leads statistical programming activities at the study or project level. Uses statistical software (mainly SAS) to create and maintain macros, listings, tabulations, graphical summaries, and formal statistical estimates and tests. Creates datasets in a standard format (i.e., SDTM), analysis datasets, assesses quality of data analysis programs, and develops automated analysis tools where appropriate. Develops programs to assist with data review such as edit checks and custom listings.

May be responsible for data integration used for clinical summaries and/or creation and quality control of statistical submission components to regulatory agencies. May partner with biostatisticians and clinical data management staff in establishing standards for clinical data collection, management and/or reporting of data.  
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* Essential Duties And Responsibilities:

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* • Serve as macro librarian responsible for maintaining existing macros, providing training on macro usage, developing documentation and training materials, being point of contact for macro questions, facilitating meetings to discuss enhancements to existing macros with stakeholders and identifying requirements for new macros and standard programs   
• Follow SDLC (Software Development Lifecycle) to create new global macros and standard programs to meet department needs   
• Independently develop SAS or other programs, and specifications, for use in study or other analyses, such as Integrated Safety Summaries.

• As the lead or support programmer on studies, work with clinical data management staff and biostatisticians to coordinate and schedule data transfers and the delivery of required outputs   
• As the lead programmer, responsible for helping to identify when additional programming resources are needed for a project, communicating with their supervisor to arrange for those resources, and coordinating and overseeing other statistical programmers’ work on the project as needed.

• Oversee the development of datasets in ODS, SDTM, & ADaM format by CROs, including clear documentation of the process that was followed in the form of specifications, trackers, and checklists.

• Responsible for programming QC oversight of CRO deliverables such as analysis datasets and tables, listings, and figures (TLFs).

• Must be able to program defensively, check results, and consistently produce accurate output.

• Adhere to FDA regulations regarding training records, guidelines, and SOPs.

• Adhere to company SOPs/WIs and department guidelines.

• Produce study datasets and programs that will help meet CDISC standards.

• Support ad-hoc requests as needed.

• Work on multiple tasks at the same time and prioritize tasks to meet business needs.

• Trouble-shoot technical and project issues.

• Help with the infrastructure development of the department.

• Assist team to ensure timelines for the study and/or project are met.

• Assist with training new employees and contractors, in particular on macros, study specifics and departmental programming conventions and standards.

• Communicate with outside departments and/or groups.

• Meet timelines on a regular basis.  
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* Supervisory Responsibilities:

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* • None  
** EDUCATION/EXPERIENCE/KNOWLEDGE &

SKILLS:

**** Education/

Experience:

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* • BS/BA degree in related discipline and a minimum of eleven years of related experience; or,   
• MS/MA degree in related discipline and a minimum of nine years of related experience; or,   
• PhD in related discipline and a minimum of five years of related experience; or,   
• Equivalent combination of education and experience.

• May require certification in assigned area.  
** Experience/The Ideal for Successful Entry into Job:*
* • At least eight years' experience in Pharmaceutical/Biotech programming.

• Demonstrated proficiency in SAS/Base, SAS/Stat, and SAS/Macros.

• UNIX, CDISC, and SAS graphics experience desirable.

• Experience with Oncology clinical trials a plus.

• NDA submission experience a plus.  
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