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Manager of Statistical Programming

2 months ago

San Francisco, California, United States Elan Solutions LLC Full time
Job Overview

Position: Manager of Statistical Programming (Full Time, Remote)

Company: Elan Solutions LLC

Salary Range: $150,000 - $153,800

Essential Qualifications:

  1. Minimum 5 years of experience in a Contract Research Organization (CRO)
  2. At least 3 years of experience as a Study Lead
  3. 3+ years in Personnel Management
  4. Ability to work within Pacific Time Zone
  5. Experience across diverse therapeutic areas
  6. Strong communication skills, both verbal and written

Position Summary:

We are looking for a dedicated Manager of Statistical Programming with substantial experience in CRO and clinical settings. The ideal candidate will possess a strong attention to detail and a proactive approach to their work. If your experience aligns with the qualifications listed, we encourage you to consider this opportunity.

Key Responsibilities:

  • Lead statistical programming efforts for various products and studies, acting as the primary contact for programming communications and overseeing task distribution.
  • Provide independent support to statisticians for both planned and ad hoc analyses, demonstrating proficiency in SAS programming.
  • Develop and execute statistical programs to generate analysis databases, tables, listings, and figures for clinical trial documentation.
  • Manage programming resources across multiple studies, serving as a key reference for other statistical programming leads.
  • Deliver timely assistance to study teams regarding programming issues, ensuring data integrity and adherence to project timelines.
  • Implement programming and project standards to facilitate the production or validation of CDISC SDTM, ADaM datasets, and other essential deliverables.
  • Ensure compliance with quality control protocols for all statistical programming tasks.
  • Assist in the creation, implementation, maintenance, and validation of the SAS macro library and other tools to enhance programming efficiency.
  • Establish and uphold programming procedures to standardize CDISC and other regulatory requirements.
  • Participate in initiatives aimed at improving biostatistical programming processes.
  • Contribute to the formulation of plans for biostatistical programming, focusing on structure, workflow, standardization, productivity enhancement, and future growth.
  • Provide mentorship and guidance to fellow statistical programmers.
  • Contribute to the development and upkeep of Standard Operating Procedures (SOPs) and training materials for statistical programming.
  • Engage in internal study team and client meetings as necessary.

Education and Experience Requirements:

  • Degree: B.S. or B.A. in Computer Science, Statistics, or a related scientific field.
  • Experience: At least 12 years of SAS programming experience, with a minimum of 6 years managing clinical study data in a CRO or pharmaceutical/biotech environment.

Knowledge & Skills Required:

  • Advanced expertise in SAS Base, SAS Stat, SAS Macro, and SAS Graph.
  • Proficient understanding of CDISC standards and regulatory submission processes.
  • Familiarity with additional programming languages such as R or Python is advantageous.
  • Demonstrated capability in preparing, processing, and analyzing clinical data using SAS code or macros.
  • Experience across all phases of clinical studies, including submissions.
  • Exposure to various therapeutic areas and indications.
  • Ability to process clinical data necessary for statistical analysis and support the creation of summary tables, data listings, graphs, and CDISC datasets for regulatory submissions.
  • Minimum of 4 years of experience in personnel management.
  • Proficient in managing multiple projects with competing deadlines.
  • Exceptional oral and written communication skills.
  • Ability to work effectively in a collaborative, multidisciplinary environment.