Associate Director of SAS Programming - Waltham, MA | Biospace
Get Our FREE Industry eNewsletter

Associate Director of SAS Programming

Alkermes

Apply
Location:
Waltham, MA
Posted Date:
12/2/2016
Position Type:
Job Code:
6637
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

Primary Responsibilities:

  • Designs, develops, evaluates, validates and modifies computer programs using SAS to analyze clinical data
  • Ability to produce and deliver standard datasets, program edit checks and produce quality tables, figures and listings in a timely fashion and high quality
  • Thorough knowledge of CDISC theory and implementation guidelines, able to create and validate CDISC standard datasets with minimal instruction or input from the supervisor
  • Provides input in the design and development of clinical trial protocols,  case report forms and clinical databases
  • Reviews eCRFs (Case Report Form) to ensure consistency with protocol and adequacy in collecting data to meet objectives defined in the protocol
  • Annotated eCRFs and writes SDTM programming specifications
  • Develops ADaM programming specifications in collaboration with biostatisticians and other clinical development colleagues
  • Works closely with clinical operations, data management and statisticians to generate  and validates statistical output - tables/listing/figures  
  • Liaise with vendors as needed to facilitate electronic data transfers and statistical programming
  • Good project management skills, CRO oversight skills, professional attitude, self improvement mentality with positive attitude
  • Good written and oral presentation skills and ability to communicate effectively Ability to think creatively and independently, and to form sound opinions and make sensible decisions in a dynamic environment

Requirements

Education and Experience Requirements:

  • Minimum Master’s degree with strong analytical skills
  • Experience 8+ years in a pharmaceutical/biotech, CRO setting
  • Excellent SAS programming and analytical skills using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS
  • Strong CDISC SDTM and ADaM experience
  • Experience electronic FDA submission, a plus
  • Excellent working knowledge of SAS/BASE, SAS/STAT, SAS/GRAPH and SAS Macro language
  • Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
  • Strong interpersonal, organizational, and multi-tasking skills
  • Excellent attention to detail and problem solving skills
  • Good project management skills, CRO oversight skills, professional attitude, self improvement mentality with positive attitude
  • Good written and oral presentation skills and ability to communicate effectively
  • Ability to think creatively and independently, and to form sound opinions and make sensible decisions in a dynamic environment

Physical Demands and Work Environment:

  • In-house full time position

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

#LI-EK1

BSP