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Biostatistics • lynn ma

[last_updated.last_updated_variable_days]
Manager, Biostatistics

Manager, Biostatistics

PROMETRIKA, LLCCAMBRIDGE ,MA, Cambridge, MA, US
[job_card.full_time]
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...[show_more][last_updated.last_updated_30]
Director Biostatistics (Oncology)

Director Biostatistics (Oncology)

BioNTech SECambridge, MA, United States
[job_card.full_time]
Cambridge, US | full time | Job ID : 9661.As Director Biostatistics (Oncology) you will collaborate with strategic clinical development partners in harmonizing statistical analysis standards and to ...[show_more][last_updated.last_updated_variable_days]
Biostatistics Director (Hybrid)

Biostatistics Director (Hybrid)

VertexBoston, MA
[job_card.full_time]
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...[show_more][last_updated.last_updated_30]
Associate Director, Biostatistics

Associate Director, Biostatistics

AlnylamCambridge, MA, United States
[job_card.full_time]
Associate Director, Biostatistics.The Associate Director, Biostatistics is responsible for statistical activities in support of clinical trials, including contributing to trial designs, authoring s...[show_more][last_updated.last_updated_variable_days]
Biostatistics Associate Director (Hybrid)

Biostatistics Associate Director (Hybrid)

Ver-TexBoston, MA, United States
[job_card.full_time]
Associate Director, Biostatistics.The Associate Director, Biostatistics will perform sophisticated scientific statistical analyses in support of the company's Global Medicines Development and Affai...[show_more][last_updated.last_updated_variable_days]
Director / Senior Director Biostatistics

Director / Senior Director Biostatistics

NovartisCambridge, MA, United States
[job_card.full_time]
As the Director / Sr Biostatistics, you will influence and drive statistical strategy / innovation directly taking part in cross-functional collaboration and decision making for program(s) across multi...[show_more][last_updated.last_updated_variable_days]
Director, Biostatistics

Director, Biostatistics

Aura BiosciencesBoston, MA, United States
[job_card.full_time]
Aura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors that aim to preserve organ function. Our lead candidate, bel-sar (AU-011), is cu...[show_more][last_updated.last_updated_variable_days]
Senior Director, Biostatistics

Senior Director, Biostatistics

ConfidentialBoston, MA, United States
[job_card.full_time]
Senior Director, Biostatistics.Pioneering biotechnology company.The Company is in search of a Senior Director of Biostatistics to lead a team of biostatisticians and provide strategic statistical i...[show_more][last_updated.last_updated_variable_days]
  • [promoted]
Associate Director, Biostatistics

Associate Director, Biostatistics

Alnylam PharmaceuticalsCambridge, MA, United States
[job_card.full_time]
Associate Director, Biostatistics.The Associate Director, Biostatistics is responsible for statistical activities in support of clinical trials, including contributing to trial designs, authoring s...[show_more][last_updated.last_updated_30]
Director, Biostatistics

Director, Biostatistics

Amylyx Pharmaceuticals IncCambridge, MA, United States
[job_card.full_time]
Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs.Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, an...[show_more][last_updated.last_updated_variable_days]
Biostatistics Director (Hybrid)

Biostatistics Director (Hybrid)

Vertex PharmaceuticalsBoston, MA, United States
[job_card.full_time]
The Director, Biostatistics will independently perform highly scientific statistical functions in support of the company's Global Medicines Development and Affairs (GMDA) area on new and complex is...[show_more][last_updated.last_updated_variable_days]
Associate Director, Biostatistics

Associate Director, Biostatistics

Otsuka America Pharmaceutical Inc.Boston, MA, United States
[job_card.temporary]
Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy : "Otsuka-people creating new products for better health worldwide. Otsuka researches, develops, manufacture...[show_more][last_updated.last_updated_variable_days]
  • [promoted]
Vice President, Biostatistics

Vice President, Biostatistics

Amylyx PharmaceuticalsCambridge, MA, US
[job_card.full_time]
Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs.Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, an...[show_more][last_updated.last_updated_variable_days]
Statistical Project Leader, Biostatistics

Statistical Project Leader, Biostatistics

SanofiCambridge, MA, United States
[job_card.full_time]
Statistical Project Leader, Biostatistics.Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families.Yo...[show_more][last_updated.last_updated_variable_days]
Director, Biostatistics

Director, Biostatistics

Alexion PharmaceuticalsBoston, MA, United States
[job_card.full_time]
The Director, Biostatistics has sufficient experience in the pharmaceutical industry to independently lead a biostatistics team to deliver project and / or technical level activities related to desig...[show_more][last_updated.last_updated_variable_days]
Associate Director, Biostatistics

Associate Director, Biostatistics

PfizerCambridge, MA, United States
[job_card.permanent]
Phase 1-2 studies and under the direction of a Director of Biostatistics, or above, as the study statistician for Phase 3 studies. Is an individual contributor role who specializes in creating clini...[show_more][last_updated.last_updated_variable_days]
Assoc. Director, Biostatistics

Assoc. Director, Biostatistics

InteProsCambridge, MA, United States
[job_card.full_time]
Associate Director, Biostatistics.We are looking for an experienced.Associate Director, Biostatistics.This role supports high-profile projects while managing a team of biostatisticians to ensure th...[show_more][last_updated.last_updated_variable_days]
Statistical Project Leader, Biostatistics

Statistical Project Leader, Biostatistics

Sanofi GroupCambridge, MA, United States
[job_card.full_time]
Statistical Project Leader, Biostatistics.Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families.Yo...[show_more][last_updated.last_updated_variable_days]
Director, RWE & Biostatistics

Director, RWE & Biostatistics

PutnamBoston, MA, United States
[job_card.full_time]
Putnam is seeking to hire Director of Real-World Evidence [RWE] & Biostatistics.This role offers the opportunity to join a global team of more than 30 statisticians, mathematicians, epidemiologists...[show_more][last_updated.last_updated_variable_days]
Manager, Biostatistics

Manager, Biostatistics

PROMETRIKA, LLCCAMBRIDGE ,MA, Cambridge, MA, US
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.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

Management Responsibilities :

  • Lead and supervise junior level biostatisticians and provide mentoring and guidance using positive, progressive, and proactive management style
  • 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

Biostats 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

    • EDUCATION

  • Master’s degree in statistics or biostatistics, PhD preferred

    • EXPERIENCE

  • Knowledge of SAS statistical computing package is a must.
  • Knowledge of other database management and statistical software packages is a plus
  • Must have a minimum of 10 years of experience in clinical trials, including protocol design activities
  • Minimum of 1 year of staff management experience required

    • SKILLS

  • Experience with general linear models, mixed models, survival analysis, categorical data analysis and non-parametric methods
  • Proficiency in SAS statistical programming
  • Knowledge of other statistical and data management software packages is a plus
  • 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.