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Manager / Senior Manager, Statistical Programming

Company: Heron Therapeutics, Inc.
Location: San Diego
Posted on: June 13, 2021

Job Description:

The Manager / Senior Manager, Statistical Programming will be responsible for providing statistical programming support for assigned clinical trials. The incumbent will work closely with Biostatisticians and Data Managers to create SAS programs for independently validating selected tables, listings, and figures produced by programming vendors, for ad-hoc analyses, and to assist with data cleaning and query generation. This position will also serve as a contact for programming activities being performed at CROs.

ESSENTIAL DUTIES & RESPONSIBILITIES:

  • Provides expert support and direction regarding statistical programming design to ensure timely, targeted, and accurate reporting and outcomes from assigned projects and ad hoc requests. Provide SAS programming support for Heron studies.
  • Supervise the activities of junior and contract statistical programmers and help on-board new team members as appropriate.
  • Review and approve SAS programming instructions and CDISC/ADaM specifications and define.xml.
  • Manage programming CROs providing oversight for programming deliverables.
  • Lead the development of relevant procedures and processes, including SOPs, to ensure that statistical programs are properly documented and validated according to generally recognized industry and regulatory standards.

REQUIREMENTS:

  • Bachelor's Degree or higher.
  • Excellent SAS programming skills including knowledge of graphical procedures such as SAS macro language, PROC SGPLOT and the graphics template language (GTL).
  • Minimum of 5 years of experience in SAS programming in a clinical research setting, including academic and/or industry experience in all phases of clinical research.
  • Knowledge of pharmaceutical and regulatory requirements, procedures, and policies with a minimum of 5 years of pharmaceutical experience.
  • Knowledge of GCP, ICH, 21 CFR part 11, and other Guidance documents and policies related to clinical trials operations requirements.
  • Knowledge of CDISC and ADaM dataset structures and requirements.
  • Knowledge of all aspects of clinical drug development (Phase 1-4).
  • Excellent computer skills; strong verbal and written communication skills.
  • Ability to work well in a team environment with an open, engaging, and transparent work style.
  • Global perspective and mindset; ability to work effectively with colleagues from other countries.
  • Ability to competently manage multiple competing priorities, switching priorities quickly as needs change. Must be comfortable working in a fast-paced environment.
  • Demonstrated very high level of technical skill and expertise as pertains to statistical programming for support and development.

The above description is intended to describe the general nature of the job that may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

Heron is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity.

Keywords: Heron Therapeutics, Inc., San Diego , Manager / Senior Manager, Statistical Programming, Other , San Diego, California

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