Associate Director, Statistical Programming

8 - 10 years experience  •  Pharmaceuticals & Biotech

Salary depends on experience
Posted on 06/22/18
Waltham, MA
8 - 10 years experience
Pharmaceuticals & Biotech
Salary depends on experience
Posted on 06/22/18

Primary Responsibilities

  • Lead one or more programming projects following company standards, processes, tools and applications
  • Effectively design/develop SAS programs and the programming specifications for producing and validating CDISC ADaM datasets to support the generation of tables, figures and listings for clinical study report and/or FDA submission in a timely fashion and high quality
  • Work closely with clinical operations, data management and statisticians to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, and product launch
  • Coordinate and oversee the preparation, execution, reporting and documentation of statistical programming activities, proactively identifying issues and recommending solutions
  • Provide project management and technical guidance to ensure operational and technical excellence
  • Liaise with vendors as needed to facilitate electronic data transfers and statistical programming
  • Good project management skills, CRO oversight skills, professional attitude, self-improvement mentality with positive attitude
  • Good written and oral presentation skills and ability to communicate effectively
  • Mentor junior level staff in programming practices, implementation of standards and project management

 

 

Education and Experience Requirements

  • Minimum Master’s degree with strong analytical skills
  • Experience 8+ years in a pharmaceutical/biotech, CRO setting
  • Strong hands-on SAS programing skills for clinical trialreporting
  • Excellent SAS programming and analytical skills using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS
  • Strong CDISC SDTM and ADaM experience
  • Experience electronic FDA submission, a plus
  • Excellent working knowledge of SAS/BASE, SAS/STAT, SAS/GRAPH and SAS Macro language
  • Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
  • Strong interpersonal, organizational, and multi-tasking skills
  • Excellent attention to detail and problem solving skills
  • Good project management skills, CRO oversight skills, professional attitude, self-improvement mentality with positive attitude
  • Good written and oral presentation skills and ability to communicate effectively
  • Ability to think creatively and independently, and to form sound opinions and make sensible decisions in a dynamic environment

 

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