Biotech/Pharmaceutical

Associate Director, Statistical Programming

Permanent

Penfield Search Partners

Contact: Linda Aronova – laronova@penfieldsearch.com

Position Summary: The Associate Director of Statistical Programming will be primarily responsible for overseeing statistical programming activities for multiple clinical studies, maintaining programming infrastructure and ensuring compliance with SOPs to produce quality and timely deliverables. He/she must possess extensive experience and proven skills in the use of SAS within a Statistical Programming environment and complete knowledge and understanding of the statistical programming processes, procedures, and roles.  He/she will use knowledge of CDISC SDTM and ADaM standards to support Biostatistics in statistical analysis, including generating analysis data listing, tables, and figures and create all files necessary to support an electronic submission in the eCTD format. Additionally, the successful candidate will use his/her strong people management skills and supervisory skills to provide direct line management to the statistical programmers, identify training needs and opportunities for optimizing staff utilization and employing the most efficient practices.

Principal Responsibilities: Serve as the Lead Programmer and Manager of the statistical programming efforts. This may include additional responsibilities including, but not limited to:

  • Develop and validate technical programming specifications for analysis datasets using company or ADaM standards.
  • Independently develop and validate programs that generate analysis datasets based on company or ADaM specifications.
  • Develop and validate technical programming specifications for protocol specific efficacy tables, listings, figures/graphs.
  • Independently develop and validate programs that generate protocol specific efficacy tables, listings, figures/graphs using company specifications.
  • Ensuring that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit.
  • Provide secondary reviews of Statistical Programming deliverables.
  • Directly support the Clinical and Statistical Programming Director in all aspects of the management and development of the Statistical Programming team.
  • Participate in the ongoing review of the processes used by the Statistical Programming group to ensure processes are continually complied with and updated as necessary.
  • Create and/or review programming plans, and ensure appropriate resource allocation and prioritization.
  • Act as the primary department contact, when necessary, to ensure that department standards are implemented in all studies.
  • Manage adherence to all company policies, SOPs, and other controlled documents; and ensure all programming activities adhere to departmental standards
  • Assume direct line management responsibility of the statistical programmers, conducting performance reviews, setting and regularly reviewing objectives, providing guidance and mentoring, and developing and regularly reviewing training and career development plans.
  • Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within company to address their needs for programming support.
  • Serve as an Administrator of the SAS Software on the Department Servers.
  • Any other activities as required.

Qualifications:

  • BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area.
  • 7+ years statistical programming experience in the CRO or Pharmaceutical Industry.
  • 2-5 years people and project management experience in the CRO or Pharmaceutical Industry. Experience with CDISC SDTM and ADaM models and transforming raw data into those standards.
  • Strong people management skills and supervisory skills gained from direct line management or supervisory experience. Proven abilities to lead and manage cross-functional projects, and people, from concept to completion.
  • Strong verbal and written communication skills – ability to clearly and effectively present information.
  • An excellent understanding of the roles and responsibilities of all related disciplines, in particular Biostatistics, Clinical Data Management, and Pharmacovigilance.
  • Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment with a demonstrated mastery of SAS/STAT procedures.
  • Extensive experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate analysis datasets, tables, listings, and figures/graphs.
  • Knowledge of clinical database design, specifically electronic data capture using Inform, Medidata, and Oracle.

Advanced experience with:

  • Constructing technical programming specifications.
  • Relational Databases.
  • Good Clinical Practices.
  • Good Programming Practices.
  • 21CFR Part 11 Standards.
  • Integrated Summary Safety/Efficacy Analyses.
  • Safety data and Coding Dictionaries (MedDRA and WHODD).
  • Creating all files necessary to support an electronic submission in the eCTD format

 

 

 

Tagged as: Associate Director, Statistical Programming