SDTM Statistical Lead (Central Region)

Biostats & Data Management & Medical Chicago, Illinois


Description

SDTM Statistical Lead

Work Location - Home ( (Central Region)

Do you possess a mindset to accelerate Clinical Trials using Data and Analytics, do you believe in extreme disruption of the clinical data management and clinical operations process? If yes, Saama is looking out to hire you as we believe it should not take this long to get Drugs out to Market, we believe data and analytics powered by Machine Learning and Artificial Intelligence if put to proper use within Clinops and Data Management organizations can bring significant time and outcome savings. We have re-imagined data-management processes and helped organizations significantly bring down the time it takes to lock a database by upto 95% for Vaccine studies, we don't want to stop here, we want to recognize process inefficiencies in clinical operations and data management and disrupt them. We are firm believers in re-imagining data management and analytics, what we have done so far is just scratching the surface, a lot more has to be done with you on our team leading some of these transformational initiatives.

 

Key relationships:

  • Sponsor Executives (C-Suite, SVP/VP, Directors)
  • Industry Thought Leaders, Heads of CRO’s
  • Heads of Clinical Operations and Data Management

 

Requirement

  • Graduate / Post-Graduate degree in Statistics / Engineering/ Pharmacy
  • Over 8 +years of experience as a Programmer/ Manager of programming experience in clinical domain       
  • Sound knowledge of regulatory guidance documents such as ICH-E3 and ICH-E9
  • Good knowledge and understanding of CDISC SDTM, ADaM standards and TFL
  • Must have extensive SDTM domain knowledge, writing SDTM specifications for entire study, Annotating CRFs and generating mapping/annotations for new/custom forms.
  • Programming in SAS/Python for analyzing data and producing safety and efficacy SDTM, ADaM, Tables, Listings and Figures in specified formats as per SAP for phase I to phase IV trials
  • Creation and review of programming specifications for SDTM and ADaM
  • Programming in SAS/Python for creation of SDTM and ADaM as per the specification document for
  • Performing quality checks for all the reports generated by the team members and also do the validation of new/ modified SAS/Python programs and macros
  • Coordinate and communicate effectively with primary contacts at Client teams to ensure satisfactory progress of project work and timely resolution of issues
  • Maintain current knowledge of statistical programming practices and developments in the industry
  • Enhance other skills such as management, supervision, presentation, communication
  • Demonstrate and promote Saama global value system across all interactions

 

LSAC provides customers with the ability to leverage advances in technology, AI, and precision medicine to connect, contextualize, and analytically converse with all their drug development data assets. It accelerates time to market and positively impacts patient lives. The combination of Saama’s AI research, advanced technical & analytics capabilities, domain expertise across the drug development life cycle, and successful product co-development approach has made Saama a trusted partner and thought leader in the life sciences industry. Saama is committed to finding the best people because the innovations and discoveries that enabled together leads to better technologies, better treatments, and a better future

 

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment, including but not limited to, computers, phones, and photocopiers.

 

Physical Demands

This position requires the frequent and repetitive use of a computer, keyboard, and mouse. Hand and finger dexterity is required. 

 

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

 

EEO 

Saama Technologies, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

 #LI-AG1