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Kura Oncology
Boston, MA, United States
Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of. At Kura Oncology, we are working to change the paradigm and improve the sc
Job Source: Kura OncologyStratacuity
Waltham, MA, United States
Associate Director/ Director Biostatistician 2024364 Location: Waltham, MA (Hybrid) Therapeutic Area: Immuno-Oncology Job Overview: This role will lead statistical analyses for early development of clinical trials, support investigators and researchers on experimental design, and collaborate closely with internal teams while reporting to the Head o
Job Source: StratacuityStratacuity: Proven Scientific Placement
Waltham, MA, United States
Location: Waltham, MA (Hybrid) Therapeutic Area: Immuno-Oncology Job Overview: This role will lead statistical analyses for early development of clinical trials, support investigators and researchers on experimental design, and collaborate closely with internal teams while reporting to the Head of Biometrics. Primary Job Responsibilities: Lead b
Job Source: Stratacuity: Proven Scientific PlacementMassachusetts General Physicians’ Organization
Somerville, MA, United States
Job Description - Senior Biostatistician/Research Associate (PhD) (3294772) The McCance Center for Brain Health in the Neurology Department at the Massachusetts General Hospital (MGH) is a Harvard affiliated Center in Boston well poised to the discovery of interventions that promote brain health.The Clinical Trials Unit within the McCance Cent
Job Source: Massachusetts General Physicians’ OrganizationRBW Consulting
Boston, MA, United States
Welcome to the forefront of medical innovation! Here you will join a clinical-stage biopharmaceutical company that is dedicated to discovering, developing, and commercializing innovative therapies. As Associate Director of Biostatistics you will have the opportunity to utilize unique technology to develop breakthrough treatments with a strong pipel
Job Source: RBW ConsultingShine Associates
Boston, MA, United States
DIRECTOR/ASSOCIATE DIRECTOR, DEVELOPMENT POSITION SPECIFICATION Shine Associates, LLC has been retained to search, identify and recruit a Director/Associate Director, Development on behalf of our client (‘Company’). This person will report directly to the Senior Director, Development. This candidate will be located in the Boston, MA office. CONFID
Job Source: Shine AssociatesAlkermes
Waltham, MA, United States
Job Description Develop and implement a winning cheminformatics strategy that optimally utilizes state-of-the-art AI and ML technologies Derive information, insight, and knowledge from experimental and in silico data through the development, implementation, and application of AI/ML-driven predictive and generative modeling approaches Work closely
Job Source: AlkermesOSI
Boston, MA, United States
Associate Director/Director, Biomarker Position Summary PepGen is looking for a highly motivated Associate Director or Director level Biomarker scientist who will contribute to the preclinical/clinical development to support and expand their current and future pipeline. This person will be a key contributor to the clinical biomarker development an
Job Source: OSIBoston, MA, United States
ESSENTIAL JOB FUNCTIONS:
The Associate Director/Director Biostatistics is responsible for providing technical leadership and biostatistical support to Clinical Development through the design and conduct of clinical studies; review and accuracy of clinical data; the evaluation, interpretation, and reporting of study results; and regulatory submissions to the FDA and other regulatory agencies.
Independently leads the development and execution of statistical aspects for multiple complex clinical trials, including contribution to study trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions, and publications.
Participates in establishing and maintaining policies, standards, and procedures for biostatistics and programming activities.
Reviews or authors statistical analysis sections of protocols, statistical analysis plans (SAP), clinical study reports (CSR), regulatory documents or scientific publications, generates or reviews study randomization, sample size/power estimations.
Review CRF's to ensure analysis data items are included and appropriately captured.
Review of data validation checks to ensure analysis variable cleaning expectations are included.
Review of TLF Shells and TLFs.
Review of SDTM and/or ADaM programming specifications. Review of vendor data transfer specifications for that data will be included in SDTM.
Creation of a Study Data Standardization plan by program/ indication.
Ad hoc review of displays in support of publications/meeting, IDMB.
Manage timelines for creation/review/approval for stats/programming activities (SAP, SDTM, TLFs Shells, final TLFs).
Provides statistically sound scientific methodology experimental design and data analysis input to meet project objectives and FDA (and other regulatory agencies) statistical and data requirements in a clear, concise, complete, and transparent manner that provide influence on key development decisions.
Develops statistical programs to perform pre-specified or ad-hoc analyses and prepare data displays.
Performs and reports study results of statistical analyses to provide interpretation of data and sound study conclusions.
Provides leadership to the organization in evaluating alternative or innovative methods of analyzing and interpreting data, evaluates implications for study design.
Takes accountability for ensuring quality in all planning, design, and execution of assignments associated with the assigned protocol or project.
Performs other duties as assigned
JOB SPECIFICATIONS:
Ph.D. degree in statistics and 7+ years of experience (or master's degree in relevant statistics field and 10+ years of clinical trial experience) in the pharmaceutical or biotech companies, or related experience or equivalent combination of training and experience.
Proven knowledge and expertise in statistics and its applications to clinical trials.
Team player, with ability to work successfully across functions.
Demonstrated written and excellent communication and interpersonal skills, with the ability to translate statistical concepts into layman's terms.
Demonstrated leadership skills.
Proficiency with statistical programming in SAS and/or R.
Knowledgeable in CDISC standards, including SDTM, ADaM.
Familiar with ICH guidelines, FDA, and other regulatory authority guidance.
Preferably NDA experience, including eCTD submission.
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Email Alert for Associate Director/Director, Biostatistician jobs in Boston, MA, United States
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