Biostatistician (East Coast Region)

Biostats & Data Management & Medical Boston, Massachusetts


Description

Biostatistician 
Work Location - Home (East Coast Region)

Do you possess a mindset to accelerate Clinical Trials using Data and Analytics, do you believe in extreme disruption of clinical data management and Biostatistics? 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 Biostatistics 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 up to 95% for Vaccine studies, we don't want to stop here, we want to recognize process inefficiencies in Biostatistics and data management and disrupt them. We are firm believers in re-imagining data management and Biostatistics, what we have done so far is just scratching the surface, a lot more must be done with you on our team leading some of these transformational initiatives.

 

As a Clinical Business Acceleration Leader, you will engage with heads of Data Management and Biostatistics, define business transformation goals, chart out a digital data flow for our sponsors, define key performance improvement metrics and help our sponsors realize joint goals of portfolio acceleration using Saama Life Science Analytics products

 

Requirement

  • Bachelors or Master’s degree in relevant fields.
  • 10 + years of relevant professional experience in a leadership position creating SDTM & ADaM deliverables.
  • Understands how clinical studies are run and managed and submitted to regulatory agencies across the globe and has worked as a TA or compound lead for at least 5+ studies over 2+ organizations over the last 5-10 years
  • Has worked as an Associate Director of Statistical Programming for top 100 Pharma or one of the top 25 Biotech companies
  • Has significantly improved efficiency in Clinical Trials by digitizing processes, consolidating processes, or introducing extreme automation for manual processes

 

Job Responsibilities:

  • Biostatistics lead will lead solution definition for multiple clinical data analytics initiatives. Will be responsible for defining next generation solution that helps in Clinical trial effectiveness and submission pathway.
  • Strong experience with developing submission outputs – e.g. SDTM datasets, ADaM datasets, define.XML, TLG (table listing and graphs)
  • Hands on experience developing programs to create SDTM & ADaM outputs (multiple studies)
  • Ability to provide specifications for automating creation of SDTM & ADaM outputs
  • Deep expertise with EDC & other clinical data sources (e.g. Lab)
  • Deep experience in all the Biostats process ( patient data analytics, cross trial analytics)
  • Ability to create visualizations on SDTM & ADaM data
  • Experience in performing the business process SDTM & ADaM conversion
  • Should be leading a team performing the Biostats activities (preferably from Pharma or CRO)

 

Nice to have qualifications:

  • Apart from SAS ,Programming experience in another language e.g. R,python) will be a plus
  • Visualization tool (Spotfire, Qlikview, Jreview) will be a plus
  • Knowledge of machine learning will be a big plus.

 

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 home office


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, and transfer, leaves of absence, compensation, and training.

 

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