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Sr. Biostatistician

Employer
Ipsen Biopharmaceuticals, Inc.
Location
Cambridge, MA, United States
Start date
Jan 19, 2020

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Discipline
Science/R&D, Biostatistics
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown
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Job Details

The clinical and translational statistician is mainly responsible for:
  • Supporting all Digital Biometry activities when it comes to advanced statistical analysis, including modelling approaches,
  • Actively contributing to Real World Data (RWD) activities, in particular for US-based sources in strong connection with other team members,
  • Providing epidemiology insights for all Biometry activities,
  • Providing statistical support to the Clinical Biometry team in applying rigorous statistical models and analysis methodologies for clinical trials, including overseeing external vendors for outsourced activities and deliverables. .


He/She collaborates cross-functionally (within and outside Global Biometry) in understanding the needs & challenges in R&D projects, evaluating and implementing data sources, defining the best extraction and analysis methodologies, and reporting through high-standard communication skills the results of his/her analysis.

Main Responsibilities:
  • Collaborate with the Non-Hierarchical Manager to identify the needs on the ongoing clinical trials.
  • Lead study level activities under his/her responsibility in interaction with CRO statisticians.
  • Take responsibility for ensuring that the CRO statistical deliverables under his/her responsibility meet project specifications.
  • Plan, schedule and track statistical activities under his/her responsibility, to ensure high quality, timely and accurate completion of statistical deliverables.
  • Oversee CRO's activities including writing the oversight plan and documenting Quality Control performed.
  • Report to the Ipsen study/project Statistician all progresses, issues and successes
  • Provide statistical support to the entire Digital Biometry team across the different activities: modelling approaches, bioinformatics and data mining analysis,...
  • Identify, propose, develop and implement any statistical approach and methodology in line with clinical and scientific questions using "gold standard" statistical tools and coding language (Python,...)
  • Demonstrate strong analytical skills even on complex datasets
  • Participate actively, ideally with an epidemiology background, in the definition of data extraction & exploration strategy in close collaboration with stakeholders and other team members: clear scoping of the questions to be addressed, identification of assumptions, proxy, and data filtering to design Statistical Analysis Plans (SAPs) guaranteeing data quality, analysis confidence and real value to end-users.
  • Develop and implement methods & approaches for acquiring, compiling, synthesizing, extracting and reporting information taking the full benefit of internal & external data, including RWD sources, as well as "indexation" platforms. Be bold, rigorous, pragmatic in methodologies development
  • Provide critical analysis and thinking, advice and recommendations on issues based on accepted scientific understanding of diseases of interest for Ipsen
  • Restitute results with clear explanations of assumptions and limits, in an intelligible manner with a strong R&D challenges focus
  • Contribute as dev team member to squads: i) actively listen and contribute to brainstorming & modelling strategy definition; ii) challenge objectives / ways of working, ask for clarification, iii) Execute specific data extraction and analysis with innovative and rigorous mindset; iv) Prepare and contribute to restitutions to stakeholders;
  • Collaborate closely with all ISCT team member, whatever their expertise, and Pharmacometrics team to cross-fertilize and get the best out of this panel of expertise
  • Contribute to feed the vision and next steps for each therapeutic area / products development. Demonstrate an "out of the box" spirit proposing approaches that are maybe not the current way to operate
  • Passionate about data
  • Responsible, autonomous, strong sense of accountability and timely delivery, transparent, flexible with a pro-active approach
  • Ability to interact satisfactorily with staff of differing disciplines. Be bold sharing past experiences & current activities and know-how to instill dynamism and "think out of the box" behaviour within the team
  • Well-developed team player mind-set, time management, communication, presentation, analytical and interpersonal skills
  • Comfortable with changing & challenging environment, working on disruptive approach implying a lot of change management and resistance
  • Bright forward-thinking
  • Ability to manage projects: plan activities and tasks including in an agile development context, identify project constraints and dependencies, identify and mitigate risks, report on project status, produce progress metrics and communicate efficiently with external vendors as well as internal partners
  • Maintain a good network of contacts within his/her sphere of competencies to fuel team ideas / technologies


Experience:
  • Ideal:
  • 2-3 years of experience in the pharmaceutical / biotech environment in a similar position
  • First experience in epidemiology
  • First experience in clinical trials as statistician
  • Knowledge of SAS, Python, R, sbml languages
  • A knowledge of the constraints and limits of RWD will be a plus
  • A knowledge of modelling area will be a plus
  • A knowledge of the statistics field of clinical development / registration will be a plus

  • Minimum:
  • Strong statistical background, with demonstrated analytical and reporting skills
  • Robust data analysis background and significant experience in data exploration-related tasks
  • Clinical and epidemiology background
  • SAS (mandatory), SQL and Python programming experience
  • Experience of working in a transversal, multidisciplinary, multisite environment
  • Understanding of drug development process
  • Good knowledge of international standards (CDISC SDTM, ADAMs, SEND)
  • Minimal knowledge on regulatory requirements

  • Qualification:
  • Ideal: Graduated in biostatistics, epidemiology or data science
  • Minimum: Graduated in biostatistics
  • Language: English


IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

Company

Ipsen (Euronext: IPN; ADR: IPSEY) is a global, biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neuroscience and Rare Diseases. At Ipsen, we focus our resources, investments and energy on discovering, developing and commercializing new therapeutic options to provide hope for patients whose lives are challenged by difficult-to-treat diseases. Ipsen's North American operations and headquarters are located in Cambridge, Massachusetts, where our fully integrated biopharmaceutical team across External Innovation and Partnering, Research & Development (R&D), Manufacturing and Commercial collaborate. Cambridge is home to Ipsen's third global hub, in addition to R&D centers in Paris-Saclay in France and Oxford in the United Kingdom. With additional offices in Basking Ridge, N.J. and Mississauga, Ontario, Ipsen employs approximately 600 people in North America. For more information on Ipsen in North America, please visit www.ipsenus.com or www.ipsen.ca.

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Company info
Website
Phone
617-679-8500
Location
1 Main Street
Unit 700
 Cambridge
MA
02142
United States
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