Biotech/Pharmaceutical

Associate Director Statistical Programming

Permanent

Penfield Search Partners

Contact: Linda Aronova 646.882.9021 laronova@penfieldsearch.com

Position Summary:

The Associate Director/Director for Statistical Programming will manage the CROs, provide hands-on programming support to companys programs as well as contribute to the development of companys statistical programming (SP) function.  The title will be commensurate with experience. 

The individual will be responsible for managing, leading, and overseeing SP planning and operational activities to meet corporate objectives, timelines, and budgets.  They will be responsible for multiple clinical studies across multiple therapeutic areas through own effort and/or mange CROs.  The individual will work closely with cross-functional teams including biostatistics, clinical operation, clinical development, clinical data management, translational research, and other functions.  They will be responsible for working closely with external vendors and providing oversight for outsourced SP related activities.    

Working with the Head of Biometrics to build and lead the SP function, the individual will design and drive overall visions for the function, including strategical direction, operations, infrastructure, system, vendor selection, innovative technology, and talent development.  The individual may be responsible to manage junior and senior Statistical Programmer(s).

Key Responsibilities:

  • Experience with clinical trials in Gastrointestinal/Rheumatic Disease TA area, immunology or/and translation science, biomarker/big data is a plus.
  • Oversees (sometimes leads) the statistical programming of Phase 1 through Phase 4 clinical trials in large or complex development program(s).
  • Leads or manages the SP CROs to interact with Biostatisticians, Clinical Data Managers, Clinical Trial Project Managers, and other personnel to provide programming support for clinical studies.
  • Leads or performs ad hoc analyses, data integration and validation, including clinical, biomarker and non-clinical data
  • Provides comprehensive programming leadership and support to clinical development teams.
  • Ensures quality of deliverables for internal and external programming work by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and departmental SOPs, and work practices.
  • Drives the development and implementation of innovative strategies and technologies for SP.
  • Provides technical guidance to SP CROs around project conventions, standards, practices, and specifications to ensure highest quality and integrity programming deliverables.
  • Builds and manages regulatory compliant computing environment to meet Regulatory guidance.
  • Leads or manages internal or external programmers for all aspects of SP activities and validation, including SDTM and ADaM datasets, tables, listings, and figure (TFLs) for individual studies as well as ISS/ISE analyses.
  • Leads or manages internal or external programmers to provide programming support to clinical data management including reviewing and comments on CRFs, annotated CRFs, and edit check and related documents, identifying, reporting, and resolving raw data issues.
  • Lead or manages internal or external programmers for the review of statistical analysis plans, table specification, develop specification for SDTM and ADaM data sets.
  • Participates in study team meetings and address issues that may affect statistical programming.
  • Supports and participate in the preparation of clinical study reports, regulatory submissions, and annual DSUR and safety reports.
  • Works with the Head of Biometrics to manage departmental budget and execute resource planning across multiple projects.
  • Works with the Head to Biometrics to provide oversight and guidance, as well as establish key performance metrics with CROs to ensure the highest quality/integrity of SP deliverables and regulatory compliance.

Preferred Experience/Education:

  • Masters Science or advanced degree in Computer Science, Mathematics, Statistics, Biostatistics, Biostatistics, or related quantitative field.
  • Minimum of 15 years (for Director and ~ 10 years for Associate Director) of statistical programming experience within pharmaceutical clinical development that includes leading programming efforts to support regulatory filings (e.g., US, EU).
  • Minimum of 8 years (for Director or 3 years for Associate Director) of experience in managing technical professionals or CRO in a regulated environment.

Knowledge, Skills and Abilities:

  • Proficient of SAS software (i.e., Base, Stat, Graph components) and programming concepts and techniques in a regulated clinical trial setting.
  • Experience of leading early and late-phase clinical studies including programming and validation of SDTM and ADaM data sets, and TFLs.
  • Significant knowledge of the drug development process, clinical trial methodology, statistical methodologies, and regulatory requirements for drug approval.
  • Intensive experience with mentoring and training staff in clinical trials setting.
  • In-depth applied experience with CDISC standards (i.e., SDTM, ADaM) for regulatory submissions.
  • Solid understanding of statistical methods.
  • Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA. NDA/sNDA/BLA or other regulatory filing experience, including ISS or ISE experience.
  • Thorough understanding of ICH Guidelines and relevant regulatory requirements.
  • Understand CDISC standards and applicability to clinical database design/capture and reporting.
  • Strong leadership skills and teamwork spirit.
  • Excellent verbal and written communication skills and the ability to work well in a team.
  • Logical thinking, attention to details and accuracy, good organizational skills, and outstanding problem-solving abilities and influencing/negotiation skills.
  • Ability to prioritize and adapt quickly to changing business conditions with a positive attitude.
  • Ability to prioritize workload and meet deadlines, demonstrate effective use of time, and handle multiple priorities simultaneously.
  • Capable of actively identifying project challenges and risks and proposing appropriate solutions to issues.
  • Effective leadership skills and proven ability to foster team productivity and cohesiveness in a dynamic and growing organization.
  • Willing to travel if required.

Tagged as: Associate Director, Statistical Programming

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