Scientist, Statistical Programmer, SAS, R

Domain: HealthTech
Career Path: AgileData
Type: Full Time preferred

Seniority: Mid senior level
Location: Cambridge or MetroWest, MA

Skills

  • 5+ years relevant work experience within an organization with a focus on analysis and data management
  • 3+ years SAS Base programming with 7+ years using SAS STAT, GRAPH and MACRO
  • 3+ years relevant industry experience
  • 3+ years clinical trial experience
  • + years clinical database experience
  • CDISC and/or submissions experience

Education

BS/BA, MS, Ph.D. preferred
Life Sciences degree preferred: Biology, Chemistry, Physics, Bioinformatics, and/or Mathematics

Experience

Description

We are searching for a Senior Analyst with Scientific background with Statistical Programming skills. You will lead and oversees statistical programming activities internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components and ad hoc analyses. He/she partners with Biostatistics to deliver high quality, submission ready statistical outputs.

Leads, coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects via internal and/or external staff oversight.

Authors CDISC ADaM (analysis data model) analysis dataset specifications including the identification of potential data issues or areas of critical data examination. Works with Biostatistics on defining and documenting programming endpoint algorithms.

Manage the end-to-end programming of deliverables through from CRF collections through electronic submission including preparation of electronic submissions (ESUB) components (input to reviewer’s guides, annotated CRF, define and XPTs), works with SMEs in Statistical Programming to ensure compliance to ESUB standards.

Essential Duties & Responsibilities

We are searching for a Senior Analyst with Scientific background with Statistical Programming skills. You will lead and oversees statistical programming activities internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components and ad hoc analyses. He/she partners with Biostatistics to deliver high quality, submission ready statistical outputs.

Leads, coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects via internal and/or external staff oversight.

Authors CDISC ADaM (analysis data model) analysis dataset specifications including the identification of potential data issues or areas of critical data examination. Works with Biostatistics on defining and documenting programming endpoint algorithms

Manage the end-to-end programming of deliverables through from CRF collections through electronic submission including preparation of electronic submissions (ESUB) components (input to reviewer’s guides, annotated CRF, define and XPTs), works with SMEs in Statistical Programming to ensure compliance to ESUB standards

  • Knowledge of drug development process and clinical trials
  • Knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW guidelines
  • Familiarity with Linux as well as software development packages (R, Imaging and Genomics software packages)
  • Management skills, and ability to effectively lead and collaborate across functions
  • Attention to detail including proven ability to manage some competing priorities
  • We want someone who loves the sciences with SAS R programming skills

At Arrayo, you’ll find an empowering environment where people are inspired to do great work, learning and developing quickly as professionals as they fundamentally change the way Data and Analytics Solutions & Services are delivered. Join Arrayo and you will be proud of the team we will be building together.

Scientist, Statistical Programmer, SAS, R

Submit CV now.

Arrayo is an Equal Employment Opportunity employer and as such does not discriminate against any applicant for employment or employee on the basis of race, color, religious creed, gender, age, marital status, sexual orientation, national origin, disability, veteran status or any other classification protected by applicable discrimination laws.