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Associate Director to Director, Statistical Programming

Remote with quarterly travel to HQ office in Westlake Village, CA

Position:          Associate Director to Director, Statistical Programming
Department: Global Medical-Biometrics and Quantitative Sciences
Location:         Remote with quarterly travel to HQ office in Westlake Village, CA
Reports To:    Executive Director, Biometrics

 

Position Summary

The Director of Statistical Programming will report to the Executive Director of Biometrics and be responsible for both management and technical aspects of Statistical Programming (SP) elements of clinical trials. This position will manage and coordinate statistical programming activities to ensure efficient use of resources and workflows. In addition, this position will build statistical programming standards/best practices as well as manage external resources (Contract Research Organization [CRO] or consultants).

Responsibilities

Provide technical and operational leadership to design, develop, evaluate and modify computer programs to analyze and evaluate clinical data. Oversee and manage the workflow of generating study specific and ad-hoc clinical data listings, summary tables and figures with the highest quality standards:

  • Manage statistical programming functional activities.
  • Build effective SP vendor relationships, including being involved in contract negotiation and selection of SP CROs and/or technology, as needed.
  • Oversee the work of CRO, contractors and/or direct reports to ensure on-time, on-target and within-budget results.
  • Act as a liaison between statistical programming, data management, clinical operation, subcommittees and project/study teams as needed.
  • Exercise independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
  • Act independently to determine methods and procedures on new assignments.
  • Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.
  • Coordinate and participate in the development of CDISC SDTM and ADaM files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources.
  • Manage the activities of Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, SAS/ODS and other analysis tools.
  • Interact with statisticians and other clinical teams, manage and/or perform ad hoc analysis and generate output according to the requirement.
  • Implement and contribute to statistical analysis plans; provide additional expertise in the analysis of clinical trials as it relates to protocol development, case report form design and data collection.
  • Recognize inconsistencies and initiate resolution of data problems.
  • Work on significant and unique issues where analysis of situations or data requires evaluation of intangibles.
  • Serve as the external spokesperson outside the biometrics function for programming related activities or tasks.
  • Manage the development of SAS coding and table templates for preparing, processing and analyzing clinical data.
  • Create/acquire tools to improve programming efficiency or quality.
  • Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
  • Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.

Qualifications

  • Bachelor’s degree in statistics, mathematics, epidemiology, computer science, bioinformatics, or another science related field (master’s degree preferred).
  • Ability to use professional concepts to achieve objectives in creative and effective ways.
  • Experience in the analysis of complex clinical trial data.
  • Experience managing multiple projects.
  • Solid knowledge of SAS Programming language.
  • Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat. 
  • Bilingual in Mandarin preferred.

 Director of Statistical Programming Requirements

  • Prior management/supervisory experience.
  • Minimum 15 years Pharmaceutical/Biotech programming experience with 6+ years of management experience.
  • Experience working on NDA submission.
  • Experience working with bone disease is highly desirable.

Associate Director of Statistical Programming Requirements

Minimum Requirements – Education and Experience:

  • Minimum 8 years Pharmaceutical/Biotech programming experience.
  • Priority management/supervisory experience is highly desirable.
  • Experience working on NDA submission and bone disease is highly desirable.

 

Salary Range: $180,000 – $210,000

 

About Angitia

Established in June 2018, Angitia Biopharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases. Angitia is currently studying 3 biologic product candidates in the clinic for the treatment of osteoporosis (Phase 2), osteogenesis imperfecta (OI) (Phase 1), and spinal fusion (Phase 3). Leveraging the team's extensive experience and scientific acumen in novel drug development, Angitia is committed to providing groundbreaking therapies to satisfy key unmet medical needs. The founder and the core team members of Angitia are seasoned scientific leaders in new drug discovery, development, and management from both overseas and domestic large multinational companies. The company has built an organization with offices in Westlake Village, CA and Guangzhou, China that is distinguished by world-class scientists with talents that are proficient in the pathophysiology of musculoskeletal diseases. We utilize cutting-edge technologies of genetics and molecular biology to uncover new mechanisms, signal transduction pathways and their interactions combined with computer aided drug design to identify new drug targets, and to discover and develop new biological and small molecule medicines. The company is committed to serving patients in need by carrying out innovative science including internal research and external collaborations with academics and global biopharmaceutical companies. We are seeking talented individuals who are innovative, ambitious, and great team players to join our vibrant group. 

Learn more at www.angitiabio.com

 

Benefits:

  • Medical, dental, and vision coverage for employees and their eligible dependents
  • 401(K) Retirement Plan with Company match
  • Company paid Long Term Disability Coverage
  • Company-paid life Insurance & AD&D Coverage
  • Voluntary Life Insurance & AD&D Coverage
  • Employee Assistance Program (EAP)
  • Company-paid Holidays
  • Vacation
  • Paid Sick Leave
  • Telecommunication Monthly Stipend
  • Work-From-Home Equipment Reimbursement

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