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ADAM SME - Biomedical Data Stewardship Mgr

Aditi Consulting

Thousand Oaks, California, United States, CA

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JOB DETAILS
SALARY
$60–$65 Per Hour
SKILLS
Analysis Skills, Artificial Intelligence (AI), Automotive Automation, Biomedicine, Biostatistics, Biotech and Pharmaceutical, CSS (Cascading Style Sheet), Clinical Data, Clinical Data Interchange Standards Consortium (CDISC), Clinical Practices/Protocols, Clinical Support, Clinical Trial, Communication Skills, Consulting, Continuous Improvement, Data Collection, Data Management, Data Structures, JavaScript, Messaging Technology, Metadata, Microsoft Visual Basic for Applications (VBA), Programming Languages, Purchasing/Procurement, Python Programming/Scripting Language, R Programming Language, Regulations, SAP, Short Messaging Service (SMS), Speech Technology, Standards Development, State Laws and Regulations, Statistical Programming Languages, Stewardship, Support Documentation, Team Player, Telephony
LOCATION
Thousand Oaks, California, United States, CA
POSTED
5 days ago
Payrate: $60.00 - $65.00/hr.
 
Summary:
In this role, we are looking for individuals with a strong understanding of end-to-end standards and data flow. Keeping the “end-in-mind” as we partner within the Biomedical Data Stewardship (BMDS) team to ensure the correct data is being collected with our standard protocol and SAP language and data collection standards for analysis and reporting purposes. The position will primarily work within BMDS but may also collaborate with statisticians and statistical programmers at Company to promote the usage of standards. This role will have an opportunity to work across Company’s therapeutic areas to create and maintain clinical trial data standards. This role will also have the opportunity for the development of a standards data repository connecting the ADaM standards with the table, figure, and listings standard specifications.
 
Responsibilities:
  • Build a comprehensive understanding of Company’s data standards structure across stages of development
  • Build a comprehensive understanding of the Metadata Repository (MDR) product
  • Develop mappings between Company’s ADaM and tables, figures, and listings standards within MDR
  • Develop and maintain guidance documents supporting the analysis and reporting standards
  • Ensure that decisions with respect to ADaM implementation are ADaM-compliant and are in line with industry and regulatory guidance
  • Provide input to continuously improve the management of analysis and reporting standards and metadata
 
Basic Qualifications:
  • Doctoral degree and 4 years clinical trials experience OR
  • Master’s degree and 6 years clinical trials experience OR
  • Bachelor’s degree and 8 years clinical trials experience
  • Proficient in CDISC ADaM modeling and CDISC IGs and TAUGs
  • Effective communication and collaboration skills
 
Preferred Qualifications:
  • 10 or more years of pharmaceutical/biotech experience in data management, biostatistics or programming
  • Proven standards development experience
  • Experience in designing, analyzing, and reporting clinical trials
  • Experience working with multiple relevant programming languages (for example, SAS, R, JavaScript, CSS, Python, VBA, etc.)
  • Independent and self-motivated
 
Top 3 Must Have Skill Sets:
  • Extensive clinical trial support with emphasis on the creation of specifications for ADaM data and tables, figures and listings including the usage of standards
  • Proficient in CDISC ADaM modeling and CDISC IGs and TAUGs
  • Strong understanding of end-to-end standards and data flow
 
Pay Transparency: The typical base pay for this role across the U.S. is: $60.00 - $65.00 /hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match,  life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. 

Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
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Aditi Consulting