Manager, Statistical Programming in Watertown, MA at APEX Systems

Date Posted: 11/21/2019

Job Snapshot

Job Description

Job #:  1014539
Manager of Statistical Programming, 1014539
Job Scope & Purpose:
Our client is seeking an experienced, motivated Manager, Statistical Programming to join a growing team! The research and development activities use a robust, chemistry-driven approach in the development of small molecule drugs for the treatment of viral infections and liver diseases. This experienced individual is responsible for designing, developing, validating and maintaining datasets and tables, listings and figures (TFLs) for ad hoc requests or regulatory submissions (in compliance with CDISC, SDTM/ADaM standards as well as regulatory business rules). This role will perform quality control checks and validation of advanced SAS codes and outputs produced by other Statistical Programmers (CROs) for SDTM datasets, AdaM datasets, and TFLs, and will assist in ensuring programming is consistent across clinical studies. The Manager, Statistical Programming may assist with reviewing SOPs for the programming and other departmental processes.
Primary Job Responsibilities:
  • Effectively designs and codes SAS programs for assigned clinical projects, consistently meeting objectives of the study
  • Codes complex SAS programs designed to analyze and report complex clinical trial data for electronic review, exchange, transformation, derivation, and submission of data in compliance with CDISC SDTM/ADaM standards as well as regulatory business/validation rules
  • Provides guidance on the resolution of highly complex clinical trial reporting problems within budget and timeline constraints while assuming high-quality standards
  • Perform quality control checks/validation of advanced SAS code and output produced by other Statistical Programmers for SDTM datasets, AdaM datasets, TFLs
  • Participate in Programming vendor selection and may be responsible for vendor oversight
  • Covert external data to SAS datasets for internal use
  • Assist with ensuring that programming activities are implemented consistently across clinical studies
  • Provide guidance on designing programming processes that are compliance with ICH GCP
  • Assist in establishing & maintaining SOPs and work instructions relevant to SAS programming.
  • Performs other duties as required/assigned

Primary Job Requirements:
  • B.S. or higher in a related field (Statistics, Computer Science, Psychology)
  • Minimum of 3 years of biopharmaceutical experience working in a programming role
  • Must have good communication skills, the ability to work independently, and willing to work efficiently
  • Excellent knowledge of statistical programming processes in clinical trials
  • Experience manipulating and analyzing SAS data, with proficiency in SAS/Base, SAS/Stat, SAS Macros, and SAS/Grap

About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
 
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. 
 
jprice@stratacuity.com
 
Code: ClinOps
 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.