Radius Health, Inc.

Senior Manager, Statistical Programmer

US-MA-Waltham | US
4 weeks ago
Job ID
2017-1629
# of Openings
1
Category
Biometrics

Overview

Radius Health  is a science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases.”

 

The successful individual will be responible for designs and writes program specifications in consultations with Biostatistician. Revises programs for corrections, enhancements, or system environment changes. Reviews statistical analysis plan and study documents and provides feedbacks to the document owners. In this role you will also assist in establishing standardized programming code and processes utilizing CDISC standards and the current technologies.

Responsibilities

  • Develop SAS programs for SDTM and ADaM datasets, patient profiles, statistical outputs (tables, figures and listings) according to statistical analysis plans (SAPs) to support clinical study reports (CSRs), regulatory submissions (integrated/pooled analyses for eCTD modules 2 and/or 5), publications (abstracts, slides, posters and manuscripts), and exploratory analyses for trial designs and data queries.
  • Work directly with biostatisticians and programmers to achieve project milestones.
  • Review SAPs and study documents from statistical programming perspective.
  • Author analysis dataset specifications and apply CDISC (SDTM and ADaM) standards to dataset programming.
  • Manage entire programming process (creation, review, completion and delivery) of assigned statistical programming activities.
  • Perform validation per the departmental SOP.
  • Review case report form (CRF) design, data management plan and edit check specifications.
  • Provide programming support to Clinical Data Management during study conduct.

Provide programming expertise in developing SAS macros and contribute innovations with the statistical programming group for efficiency and standardization

Qualifications

  • Master’s or equivalent degree in Biostatistics or Statistics.
  • 5+ years of biopharmaceutical experience, with oncology experience preferred.
  • Proficient skills with SAS STAT, SAS GRAPH and SAS MACRO.
  • Solid knowledge of CDISC and related regulatory guidance.
  • Hand-on experience in pivotal studies and/or regulatory submissions (NDA, MAA).
  • Ability to work independently with minimum supervision.
  • Excellent interpersonal, communication, problem solving, and analytical skills.

 

Equal Opportunity Employer

Radius Health, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Radius Health, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.

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