Director of SAS Programming

The Associate Director/Director will be responsible for managing all statistical programming in the R&D group. This includes managing and programming for all phases of clinical trials and regulatory documents.
• Participate in CRFs design and review
• Review and QC analysis data
• Generate tables/figures/listings for Endo experiments/clinical trials
• Provide programming support to regulatory documents
• Manage Statistical Programming resources, projects timeline and interact with vendors
• Optimize programming processes/practices and develop functional related SOPs and working practices
• Mentor and coach Statistical Programmer
Requirements Skills:
• Ability to interact effectively with people individually and in groups and to communicate with teams and non-technical colleagues
• Ability to create and manage the study file directory
• Familiar with CDISC requirements and ability to create SDTM and ADaM datasets
• Ability to program tables/figures/listings
• Ability to generate macros and use exiting macros
• Ability to work on data integration
• Familiar with SAS and clinical trial programming process
• Ability to work with vendors
• Ability to identify process/technical gaps and optimize programming practices
• Ability to develop Standard Operating Procedures (SOP’s) and work instructions
• Ability to lead and manage Statistical Programming staff

Education/Experience:
• Advanced degree in Computer Sciences, Mathematics, Engineering, Natural Science, Medical or related discipline:
• Minimum 8 years experience in SAS programming in the pharmaceutical industry
• Extensive programming experience in at least one of the therapeutic areas (pain, urology, endocrinology and oncology)
• Managerial experiences (3+ years)

Abilities:
• Proactive and positive
• Excellent problem solving skills
• Manage resource/timeline well
• Dealing with changing priorities and ambiguity

Knowledge:
• SAS and basic statistical concepts.
• Strong knowledge of one or more therapeutic areas (pain, endocrinology, urology, and oncology)
• Regulatory submission experience (eg MAA, NDA or BLA)
• Familiarity of the drug development process and safety data summary

Category:	Information Technology
Location:	Chadds Ford, PA
County:	Delaware County
ZIP Code:	19317
Pay Rate:	Negotiable
Job Terms:	full time
Company:	PSCI
Phone:	1302-334-4107
Fax:	email only