December 22, 2024
[Hiring] Biostatistician @Rqteam

 RQM+ is the main MedTech carrier supplier with the arena’s greatest international group of regulatory and high quality mavens. Construction upon 40 years of regulatory experience, we additionally supply complete medical trial, lab and repayment services and products – lowering possibility and supporting marketplace get admission to all the way through all of the product lifecycle for clinical units, virtual therapeutics and diagnostics. With extra former FDA, Medications and Healthcare Merchandise Regulatory Company (MHRA) and notified frame regulators than every other company, the RQM+ group has deep experience in all medical specialties. RQM+ these days works for 19 of the highest 20 clinical software producers and 7 of the highest 10 IVD firms.

RQM+ is the main MedTech carrier supplier with the arena’s greatest international group of regulatory and high quality mavens. Construction upon 40 years of regulatory experience, we additionally supply complete medical trial, lab and repayment services and products – lowering possibility all the way through all of the product lifecycle for clinical units, virtual therapeutics and diagnostics. With extra former FDA, Medications in Healthcare merchandise Regulatory Company (MHRA) and notified frame regulators than every other company, the RQM+ group has deep experience in all medical specialties. Along with early- and mid-stage MedTech firms, we these days paintings with 19 of the highest 20 clinical software producers and 7 of the highest 10 IVD firms.

As a biostatistician inside the Medical and Put up Marketplace Apply at RQM+, this position will collaborate with clinical writers and material mavens to give a boost to regulatory submissions for clinical units. The position shall be answerable for main statistical design for publish marketplace medical actions and research.

This position could also be answerable for growing statistical research plans, pattern dimension calculations, supply fabrics and steering to different group participants to interface and give a boost to producers in medical information assortment.

Duties:

  • Perceive the learn about from the CERs, Learn about plans and Questioners and many others. then
  • Information captured (Uncooked, Abstract and Abstract+ excel information recordsdata on this case) 
  • Test and blank the information if required carry out some validation exams.
  • Produce tables and figures in most extent to fulfill the reach deliberate targets.
  • Generate statistical file and presentation for consumer supply.
  • Liable for offering statistical steering and experience for medical research (premarket and publish marketplace) throughout quite a lot of Intuitive applied sciences, together with learn about design, research, interpretation, medical learn about file and manuscript building.
  • Act as a key strategic spouse to increase proof technology technique
  • Liable for growing Statistical Research Plan, Put up Marketplace Job Presentation Fabrics, Offering Preliminary Interpretations of Effects
  • Liable for offering statistical experience for addressing regulatory authority questions associated with statistical design and research for all pre-market medical research and publish marketplace research/ post-market medical observe up research that are overseen through regulatory government
  • Liable for accomplishing information research to give a boost to the improvement of Medical Learn about Record, Medical Analysis Record, convention or magazine publications, and different regulatory submission as wanted
  • Constitute the Biostatistics serve as inside the cross-functional groups, collaborate with different group participants for the improvement of Medical Investigational Plan, Medical Learn about Record, Case Record Shape, and different key learn about paperwork
  • Paintings intently with Information control to outline edit specs and important variable lists, give a boost to information cleansing actions to verify selection of top quality information; handles database lock and unblinding procedure consistent with learn about necessities
  • Construct sturdy relationships with learn about investigators and key opinion leaders to spot the newsletter wishes; paintings intently with inside/exterior authors to increase manuscript, summary/presentation, or poster, and supply statistical give a boost to all the way through the newsletter procedure
  • Keep abreast of new business and educational trends in Statistics and modeling tactics and observe adapting method to resolve distinctive or difficult learn about design and statistical research problems
  • Liable for managing useful resource (inside and exterior) and finances associated with statistical research to verify learn about good fortune
  • Supply management and ongoing steering for group participants to succeed in top efficiency; successfully distills complexity and gives transparent and actionable route and knowledge, assist group prioritize, clear up complicated issues that permit the group to make important development
  • Necessities:

  • Complicated level in Biostatistics or Statistics (Grasp or Ph. D) with sound wisdom of theoretical and carried out statistics
  • No less than 2-8 years of medical analysis biostats running revel in in biotech business (clinical software corporate revel in is most popular)
  • Intensive revel in within the building of Statistical Research Plan for regulatory submission, with sturdy capacity to have interaction successfully with inside and exterior groups to handle statistical questions comparable to check design and/or research
  • Confirmed observe document of good fortune in designing quite a lot of medical research with quite a lot of statistical method; revel in in adaptive design (e.g., pattern dimension re-estimation, Bayesian adaptive design) and the usage of historic regulate is most popular
  • In-depth wisdom and in depth revel in of accomplishing statistical research to give a boost to the improvement of medical learn about experiences
  • Talented in R and/or SAS programming and/or an appropriate statistical programming atmosphere
  • In a position to bridge analytics to medical interpretation and give an explanation for complicated mathematical/statistical issues to group participants and senior management
  • Enjoy for research of a big dataset (administrative or industrial information units) is fascinating
  • Sturdy wisdom of 21 CFR section 812, Excellent Medical Apply, ISO14155 and different laws/pointers on medical analysis
  • Very good verbal/written verbal exchange, presentation, teamwork and interpersonal abilities; capacity to construct sturdy cross-functional collaboration each internally and externally
  • Prime consideration to element and clinical integrity
  • Very good organizational making plans, mission control and time control abilities
  • Being an business chief in consumer give a boost to is just the start for RQM+.  Offering a rewarding position to paintings is rooted deep within the core values of RQM+.  From an business main repayment package deal to a deeply engrained focal point on paintings existence steadiness, RQM+ applies the “and method extra” technique to employment.  At RQM+, you aren’t simply every other worker, you’re a member of the RQM+ circle of relatives. Make your have an effect on nowadays!  We invite you to put up an software if you are interested in finding out extra about our group and starting your adventure as a specialist with us.  We require willingness to paintings a versatile time table and commute a minimum of 25% of the time  Task Alternative Verification At RQM+, we prioritize the protection of our process candidates. To verify a secure software procedure: All official RQM+ process alternatives are indexed on our legitimate careers web page: rqmplus.com/careers Each and every candidate going throughout the interview procedure will take part in a voice and/or video interview. Workout warning with unsolicited process provides or requests for delicate data.

    Being an business chief in consumer give a boost to is just the start for RQM+.  Offering a rewarding position to paintings is rooted deep within the core values of RQM+.  From an business main repayment package deal to a deeply engrained focal point on paintings existence steadiness, RQM+ applies the “and method extra” technique to employment.  At RQM+, you aren’t simply every other worker, you’re a member of the RQM+ circle of relatives. Make your have an effect on nowadays! 

    We invite you to put up an software if you are interested in finding out extra about our group and starting your adventure as a specialist with us. 

    We require willingness to paintings a versatile time table and commute a minimum of 25% of the time 

    Task Alternative Verification

    At RQM+, we prioritize the protection of our process candidates. To verify a secure software procedure:

    All official RQM+ process alternatives are indexed on our legitimate careers web page: rqmplus.com/careers

    Each and every candidate going throughout the interview procedure will take part in a voice and/or video interview.

    Workout warning with unsolicited process provides or requests for delicate data.

    Being an business chief in Medtech is just the start for RQM+. We imagine our staff our largest asset and we make investments closely in ongoing finding out and building. Offering a rewarding position to paintings is rooted deep in our core values. From an business main repayment package deal to a deeply engrained focal point on paintings existence steadiness, RQM+ has a singular providing for regulatory and high quality execs. At RQM+, you aren’t simply every other worker, you’re a member of RQM+ circle of relatives. Make your have an effect on nowadays! 

    We invite you to use if you are interested in finding out extra about our group and starting your adventure with us.

    Task Alternative Verification

    At RQM+, we prioritize the protection of our process candidates. To verify a secure software procedure:

    All official RQM+ process alternatives are indexed on our legitimate careers web page: rqmplus.com/careers

    Each and every candidate going throughout the interview procedure will take part in a voice and/or video interview.

    Workout warning with unsolicited process provides or requests for delicate data.

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