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Associate Director, Biostatistics

Associate Director, Biostatistics

Prometrika LLCCambridge, MA, US
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PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance.We’r...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Manager, Biostatistics

Manager, Biostatistics

Sumitomo Pharma America, IncCambridge, MA
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Japan with key operations in the U.Canada (Sumitomo Pharma Canada, Inc.Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare disea...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Manager, Biostatistics

Manager, Biostatistics

PROMETRIKA, LLCCAMBRIDGE ,MA, Cambridge, MA, US
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PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance.We’re driv...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Postdoctoral Research Fellow - Epidemiology and Biostatistics

Postdoctoral Research Fellow - Epidemiology and Biostatistics

Dana-Farber Cancer InstituteBrookline Ave, Boston, MA
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Brian Wolpin's Lab is seeking a highly motivated and skilled Postdoctoral Research Fellow to join our dynamic research team. The successful candidate will engage in cutting-edge research focused on ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Biostatistics Leader - Immunology

Biostatistics Leader - Immunology

Genentech, IncBoston
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We advance science so that we all have more time with the people we love.As the Biostatistics Leader - Immunology, you will provide strategic leadership and oversight across all Biostatisticians wi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Biostatistics Associate Director

Biostatistics Associate Director

VirtualVocationsDorchester, Massachusetts, United States
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A company is looking for an Associate Director, Biostatistics.Key Responsibilities Develops study protocols and statistical analysis plans (SAPs) for clinical trials Collaborates with teams to e...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
Senior Director, Biostatistics

Senior Director, Biostatistics

Intellia TherapeuticsCambridge, Massachusetts, United States
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Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Director, Biostatistics

Director, Biostatistics

ServierBoston, US
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Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018.As a privately held organization, Servier is uniquely positioned to advance cutting-edge science, tackle u...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Director, Biostatistics

Director, Biostatistics

PfizerCambridge,Massachusetts,United States
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The Director of Biostatistics will plan, direct, and coordinate specialized and complex global development projects of Non-Malignant Hematology within the Inflammation and Immunology & Specialty Ca...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Executive Director Biostatistics (Hybrid)

Executive Director Biostatistics (Hybrid)

Vertex PharmaceuticalsBoston, MA, US
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The Executive Director of Biostatistics is a strategic, dynamic, and empowered leader, overseeing statistical functions in support of multiple company therapeutic areas or portfolios.In addition, T...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Associate Director, Biostatistics

Associate Director, Biostatistics

Agios PharmaceuticalsCambridge, MA
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Associate Director, Biostatistics.We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, an...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Biostatistics Director (Hybrid)

Biostatistics Director (Hybrid)

VertexEast Boston, MA, US
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As a Director Biostatistics at Vertex, you will be at the forefront of cutting-edge medical research, analyzing complex data to unravel crucial insights that may lead to innovative medical breakthr...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Associate Director, Biostatistics

Associate Director, Biostatistics

BlueRock TherapeuticsCambridge, MA, United States
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BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases.T...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
Director, Biostatistics

Director, Biostatistics

Dyne TherapeuticsWaltham, Massachusetts, United States
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Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Director of Biostatistics

Director of Biostatistics

Thermo Fisher ScientificWaltham, Massachusetts, USA
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At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale.Join our colleagues in bringing our Mission to life To enable our customers to make the wo...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Director Biostatistics

Director Biostatistics

Penfield Search PartnersBoston, MA, US
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Our client is a clinical-stage biotech seeking an experienced and strategic.Director or Associate Director of Biostatistics. This is a high-impact role supporting drug development programs through e...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Director, Biostatistics

Director, Biostatistics

Alnylam PharmaceuticalsCambridge, MA, US
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Summary of Key Responsibilities.Leads large and / or complex late phase clinical development program.Represents Biostatistics and the broader Data Sciences and Statistics team including Data Manageme...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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TA Head of Biostatistics, Neuroscience and Ophthalmology

TA Head of Biostatistics, Neuroscience and Ophthalmology

SanofiCambridge, MA, United States
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Job Title : Data Governance Location : Cambridge, MA Morristown, NJ About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find an...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Associate Director, Biostatistics

Associate Director, Biostatistics

Prometrika LLCCambridge, MA, US
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Job Description

Job Description

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes.

RESPONSIBILITIES

The Associate Director, Biostatistics is responsible for supporting the leadership of the Biostatistics department, while mentoring and coaching a line of direct reports. This position is part of PROMETRIKA’s Management Team and supports the Leadership Team in aligning the positioning of Biostatistics with the company’s short-and long-term goals through departmental, and cross-departmental and company-wide initiatives. Specific responsibilities include the following :

Function Management / Leadership

  • Lead and supervise junior level biostatisticians and provide mentoring and guidance using positive, progressive, and proactive management style
  • Manage project teams of statisticians and programmers and ensure quality and timeliness of project deliverables
  • Act decisively, exercise good judgment and make effective, sound, timely and informed decisions. Seek to identify, analyze and resolve problems effectively
  • Manage project budgets and forecast resources needed for studies
  • Participate in capabilities and bid defense presentations and assist with development of budgets and proposals

Biostatistics Responsibilities

  • Provide statistical input for protocol development, study design, and CRF development by actively contributing to study design considerations in internal and client meetings, and providing and discussing sample size scenarios
  • Perform sample size calculations and write statistical methodology sections for inclusion in study protocols
  • Design statistical analysis plans and table shells in accordance with study protocols or for integrated efficacy and safety summaries for New Drug Application (NDA) submissions
  • Design analysis file specifications in accordance with the statistical analysis plan and table shells, and CDISC ADaM standards, if applicable
  • Develop SAS programs to QC statistical tables / figures / data listings
  • Develop SAS programs to produce and validate analysis datasets in CDISC ADaM or other formats specified by the sponsor
  • Review and / or write the statistical methods and results sections of clinical study reports
  • Review and / or assist in writing publications
  • Review case report forms and data validation guidelines to ensure quality and integrity of study data collection
  • Provide statistical input for Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans, and serve as an independent statistician providing data and analysis support for DMC review
  • Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical methodology and analysis
  • Make presentations in industry meetings sharing experiences / methods with the greater clinical trials community
  • Additional responsibilities as assigned by supervisor / manager

    • Thought Leadership

  • Proactively contribute to PROMETRIKA’s newsletters, thought leadership blogs, and other publications as appropriate
  • Contribute materials and present at Lunch and Learn sessions within PROMETRIKA to cross-train and share Biostatistics expertise within our organization
  • Find innovative approaches to increase PROMETRIKA’s Biostatistics footprint within the Life Sciences industry

    • Business Development Support

  • Actively collaborate and partner with the Innovations team on the implementation of new technologies and initiatives that drive PROMETRIKA’s competitive advantage
  • Partner with Business Development on efficient and timely completion of Requests for Information and Requests for Proposals, accentuating PROMETRIKA’s Biostatistics capabilities and competitive edge
  • Continuously look for opportunities to participate in bid defense meetings, proactively reaching out to and collaborating with Business Development

    • EDUCATION

  • Master’s degree in Biostatistics required
  • PhD degree in Biostatistics preferred

    • EXPERIENCE

  • Minimum of 15 years of experience in clinical trials, including protocol design activities
  • Minimum of 5 years of staff management experience required

    • SKILLS

  • Knowledge of SAS statistical computing package is a must
  • Knowledge of other database management and statistical software packages is a plus
  • Experience with general linear models, mixed models, survival analysis, categorical data analysis and non-parametric methods
  • Strong written and oral communication skills
  • Knowledge and experience with CDISC data standards and models
  • Strong project management and mentoring / leadership skills
  • In-depth knowledge of applicable clinical research regulatory requirements; e.g., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Ability to effectively manage multiple tasks and projects
  • Ability to clearly describe statistical techniques and interpret results

    • PHYSICAL REQUIREMENTS

    Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception / clarity and muscle control / coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time.