Talent.com
- (Boston)
- (Boston)Hengrui Pharma • Boston, MA, US
No longer accepting applications
- (Boston)

- (Boston)

Hengrui Pharma • Boston, MA, US
24 days ago
Job type
  • Part-time
Job description

a) /

b)

c) SAPCSRTFL

d) SAS

e) CSR TFL

f) SAPCSR

g) CRO

h)

3 CRO /

  • / SASREAST
  • GCPICH

Responsibilities

  • Functions as the lead trial statistician for clinical trials :
  • Contributes to the study design of a clinical trial, including but not limited to specifications of study objectives, endpoints, hypothesis testing strategy, sample size / power calculations
  • Author of the statistical sections of the trial protocol
  • Author of the Statistical Analysis Plan (SAP), as well as the templates of tables, figures and listings (TFLs) to be presented in the Clinical Study Report (CSR), regulatory documents, publications
  • Supports the development of SAS codes to implement the pre-planned and ad hoc data analyses, as well as to prepare data displays
  • Supports the validation of the generated study datasets and CSR TFLs, outputs for regulatory documents and publications
  • Participates in the writing, review and finalization of regulatory documents including but not limited to protocol, SAP, CSR, publications (abstracts, posters, manuscripts), etc.
  • Works collaboratively with internal and external (e.g. CRO) team members to coordinate the planning and execution of day-to-day biostatistics deliverables
  • Provides statistical interpretation and explanation of data analysis results to cross-functional teams
  • Ensures study design and statistical methods for data collection, processing and analysis are scientifically sound and can clearly and robustly address the objectives of the clinical trial and program
  • Collaborates and oversees statistical works outsourced to CRO / external vendor to ensure high quality and on-time delivery
  • Good knowledge of disease, compound and regulatory guidance within the focused therapeutic area
  • Provides good-faith challenge to the cross-functional trial team with respect to study design, data analysis and interpretation
  • Qualifications

  • Education : Master degree in Biostatistics, Statistics or an equivalent field with about 3 years relevant work experience, or a Ph.D. degree in Biostatistics, Statistics or an equivalent field
  • Experience :
  • Experience in designing clinical trials and conducting data analysis;
  • Experience of interaction with regulatory authority is preferred for MS level candidate;
  • Knowledge of / experience with SAS, R, EAST, or other business or research analytic software;
  • Knowledge of data architecture
  • Language Requirement : Fluent in both written and verbal English
  • Other Skills : Good interpersonal and communication skills
  • Requirements

  • Ability to learn and apply appropriate statistical methods to solve complex problems while also focus on quality of work
  • Knowledge of disease, compound and regulatory guidance including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Ability to work collaboratively and efficiently in a cross-functional team
  • Good communication skills and ability to build sound relationship with cross-functional team members
  • Create a job alert for this search

    Boston • Boston, MA, US

    Related jobs
    BCBA - Relocation! (Boston)

    BCBA - Relocation! (Boston)

    Action Behavior Centers - ABA Therapy for Autism • Boston, MA, US
    Full-time +1
    Join Action Behavior Centers as a BCBA.And we commit to a response within 24 hours.Join Action Behavior Centers as a BCBA. Full-Time | In-Clinic | Relocation to TX, AZ, IL, MN, NC.We're hiring Board...Show more
    Last updated: 11 days ago • Promoted
    Lateral Partner (Boston)

    Lateral Partner (Boston)

    Partridge Snow & Hahn LLP • Boston, MA, US
    Full-time
    Partridge Snow & Hahn LLP is a business law firm with offices in Providence, SouthCoast and Boston.We are seeking experienced partners who will find our collegial atmosphere, client-first cultu...Show more
    Last updated: 30+ days ago • Promoted
    Director of Sales, Northeast (Boston, MA) Boston, MA Sales

    Director of Sales, Northeast (Boston, MA) Boston, MA Sales

    Vita Coco • Boston, MA, United States
    Full-time
    The Vita Coco Company, created in 2004 by Co-CEO Michael Kirban and Ira Liran, produces the leading brand of coconut water in the United States with a growing presence around the world.The Vita Coc...Show more
    Last updated: 14 days ago • Promoted
    Expeditor Back Bay (COMING SOON) (Boston)

    Expeditor Back Bay (COMING SOON) (Boston)

    Cactus Club Cafe Boston Back Bay • Boston, Massachusetts, US
    Part-time
    Step into something new and be a key player in Cactus Club Cafe's US expansion at our upcoming Boston, Massachusetts location - building our brand as you build your career.Only candidates legally e...Show more
    Last updated: 3 days ago • Promoted
    Senior Superintendent (Boston)

    Senior Superintendent (Boston)

    CyberCoders • Boston, MA, US
    Part-time
    The Senior Superintendent will oversee all aspects of construction projects, ensuring they are completed on time, within budget, and to the highest quality standards. This role requires strong leade...Show more
    Last updated: 11 days ago • Promoted
    CRM Specialist (Boston)

    CRM Specialist (Boston)

    Zipcar • Boston, MA, US
    Part-time
    Reporting to the Engagement & Retention Manager, the CRM Specialist will be responsible for the strategy, coordination and execution of CRM activities. You will be working on an end-to-end delivery;...Show more
    Last updated: 11 days ago • Promoted
    Host Back Bay (COMING SOON) (Boston)

    Host Back Bay (COMING SOON) (Boston)

    Cactus Club Cafe Boston Back Bay • Boston, Massachusetts, US
    Part-time
    Step into something new and be a key player in Cactus Club Cafe's US expansion at our upcoming Boston, Massachusetts location - building our brand as you build your career.Only candidates legally e...Show more
    Last updated: 30+ days ago • Promoted
    Tutor (Boston, MA)

    Tutor (Boston, MA)

    Collegewise • Boston, MA, US
    Full-time +1
    Quick Apply
    Do you believe that a great instructor can inspire a student to achieve their potential? •Do you want to help more students and parents benefit from a service that makes a difference? •Are you look...Show more
    Last updated: 5 days ago
    Restaurant Management Positions-Boston

    Restaurant Management Positions-Boston

    B Hospitality Corp • Boston, MA, US
    Full-time
    Quick Apply
    About Butler Butler Hospitality serves the world’s best hotel operators (Hersha, Real Hospitality, Crescent, M&R to name a few) to increase the efficiency of their food and beverage operations....Show more
    Last updated: 30+ days ago
    Multi-Unit General ManagerBoston

    Multi-Unit General ManagerBoston

    Blank Street • Boston, MA, US
    Full-time
    At Blank Street, we believe that rituals matter, and that great rituals make your life better.With coffee shops across the US and UK, we are working to transform the high street grab-and-go coffee ...Show more
    Last updated: 30+ days ago • Promoted
    Real Estate Team Lead (Boston)

    Real Estate Team Lead (Boston)

    Vylla • Boston, MA, US
    Part-time
    Vylla Homes national footprint and full-service model provide a truly progressive approach to the real estate process, creating extraordinary experiences for both our customers and sales agents.As ...Show more
    Last updated: 11 days ago • Promoted
    General Manager (Boston, MA)

    General Manager (Boston, MA)

    DeVita & Hancock Hospitality • Boston, MA, United States
    Full-time
    About the job General Manager (Boston, MA).A rapidly growing fast-casual restaurant concept is looking for an enthusiastic and experienced. Why This Opportunity Stands Out.This is a boots-on-the-gro...Show more
    Last updated: 30+ days ago • Promoted
    Restaurant Manager Back Bay (COMING SOON) (Boston)

    Restaurant Manager Back Bay (COMING SOON) (Boston)

    Cactus Club Cafe Boston Back Bay • Boston, Massachusetts, US
    Full-time
    Step into something new and be a key player in Cactus Club Cafe's US expansion at our upcoming Boston, Massachusetts location - building our brand as you build your career.Only candidates legally e...Show more
    Last updated: 30+ days ago • Promoted
    Restaurant Manager-Boston, MA

    Restaurant Manager-Boston, MA

    Butler Hospitality • Boston, MA, US
    Full-time
    Competitive Salary! Health, Dental benefits, Vision and a 401k plan match Flexible Scheduling Provided breakfast, lunch, and dinner shift meals Growth and development opportunities.Hire, train, mot...Show more
    Last updated: 30+ days ago • Promoted
    Business Accounts - Account Manager (Boston)

    Business Accounts - Account Manager (Boston)

    Blueground • Boston, MA, US
    Full-time
    Blueground For Business Account Manager.At Blueground, we believe that when your base is reliable, the world opens up.That's why we're building the world's leading platform for living.Every year, 3...Show more
    Last updated: 30+ days ago • Promoted
    Diagnostic Sales Manager (Boston North)

    Diagnostic Sales Manager (Boston North)

    Antech Diagnostics • Boston, MA, US
    Full-time
    Antech is comprised of a diverse team of individuals who are committed to each other's growth and development.Our culture is centered on our guiding philosophy, The Five Principles : Quality, Respon...Show more
    Last updated: 30+ days ago • Promoted
    Senior IT Manager (Boston)

    Senior IT Manager (Boston)

    Lendbuzz • Boston, MA, US
    Full-time
    At Lendbuzz, we believe financial opportunity should be more personalized and fair.We develop innovative technologies that provide underserved and overlooked borrowers with better access to credit....Show more
    Last updated: 30+ days ago • Promoted
    Restaurant Manager-Boston, MA

    Restaurant Manager-Boston, MA

    B Hospitality Corp • Boston, MA, US
    Full-time
    Quick Apply
    Butler Hospitality operates the Food and Beverage Departments within our partner hotels throughout the USA, Great locations and conveniently located!. We are looking for talented Restaurant Managers...Show more
    Last updated: 30+ days ago
    Marketing Specialist (Boston)

    Marketing Specialist (Boston)

    marlo marketing • Boston, MA, US
    Part-time
    Are you seeking a role that offers that fabled mix of work / life balance? Eager to join a tribe that shares your passion for creative marketing campaigns, revenue-driving loyalty programs, and all t...Show more
    Last updated: 11 days ago • Promoted
    Asst General Manager (Boston, MA)

    Asst General Manager (Boston, MA)

    DeVita & Hancock Hospitality • Boston, MA, United States
    Full-time
    Job Title : Asst General Manager.A rapidly growing fast-casual restaurant concept is looking for an enthusiastic and experienced. Why This Opportunity Stands Out.This is a boots-on-the-ground role.Yo...Show more
    Last updated: 30+ days ago • Promoted