Biostatistics [h1.location_city]
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Biostatistics • cambridge ma
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This role provides expertise and guidance in collaboration with cross-functional groups broadly across the organization in establishing study design and analyses in addition to strategy, and instit...[show_more][last_updated.last_updated_variable_days]
Associate Director, Biostatistics.MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs...[show_more][last_updated.last_updated_variable_days]
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]
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]
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]
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]
C4 Therapeutics (C4T) (Nasdaq : CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medic...[show_more][last_updated.last_updated_variable_days]
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]
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]
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]
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]
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]
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]
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]
C4 Therapeutics (C4T) (Nasdaq : CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medic...[show_more][last_updated.last_updated_variable_days]
Director, Biostatistics Business Operations.The Director, Biostatistics Business Operations has sufficient experience in the pharmaceutical industry to independently drive the strategic planning, o...[show_more][last_updated.last_updated_30]
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]
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]
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]
Director of Biostatistics
Taylor Strategy PartnersWaltham, MA, United States[job_card.full_time]
Associate Director, Biostatistics
MannKindBedford, MA, United States[job_card.full_time]
Manager, Biostatistics
PROMETRIKA, LLCCAMBRIDGE ,MA, Cambridge, MA, US[job_card.full_time]
Director Biostatistics (Oncology)
BioNTech SECambridge, MA, United States[job_card.full_time]
Associate Director, Biostatistics
AlnylamCambridge, MA, United States[job_card.full_time]
Director / Senior Director Biostatistics
NovartisCambridge, MA, United States[job_card.full_time]
Director, Biostatistics
C4 TherapeuticsWatertown, MA, US[job_card.full_time]
Biostatistics Associate Director (Hybrid)
Ver-TexBoston, MA, United States[job_card.full_time]
Director, Biostatistics
Aura BiosciencesBoston, MA, United States[job_card.full_time]
- [promoted]
Associate Director, Biostatistics
Alnylam PharmaceuticalsCambridge, MA, United States[job_card.full_time]
Senior Director, Biostatistics
ConfidentialBoston, MA, United States[job_card.full_time]
Director, Biostatistics
Amylyx Pharmaceuticals IncCambridge, MA, United States[job_card.full_time]
Biostatistics Director (Hybrid)
Vertex PharmaceuticalsBoston, MA, United States[job_card.full_time]
Associate Director, Biostatistics
Otsuka America Pharmaceutical Inc.Boston, MA, United States[job_card.temporary]
- [promoted]
Director, Biostatistics
C4 Therapeutics IncWatertown, MA, US[job_card.full_time]
- [promoted]
Director, Biostatistics
Alexion PharmaceuticalsBoston, MA, US[job_card.full_time]
- [promoted]
Vice President, Biostatistics
Amylyx PharmaceuticalsCambridge, MA, US[job_card.full_time]
Associate Director, Biostatistics
PfizerCambridge, MA, United States[job_card.permanent]
Assoc. Director, Biostatistics
InteProsCambridge, MA, United States[job_card.full_time]
Director of Biostatistics
Taylor Strategy PartnersWaltham, MA, United States[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]Ph.D. or M.S., Biostatistics or equivalent with at least 5 years of sponsor side pharmaceutical, biotechnology, or equivalent experience. Profound understanding of advanced clinical trial design and statistical analysis methodologies Good understanding of the big picture of an overall development program Capable of thinking strategically Excellent communication and interpersonal skills Ability to lead project teams, as well as work in a cross-functional team Good leadership skills Strong ability to quickly capture key information from medical journal articles Understand regulatory requirements and good clinical practice guidelines Ability to multitask and prioritize work Good statistical programming skills using SAS and other statistical software
Description
Director of Biostatistics
The Role :
This role provides expertise and guidance in collaboration with cross-functional groups broadly across the organization in establishing study design and analyses in addition to strategy, and institutes best practices with regards to planning, execution, interpretation and regulatory submission of clinical projects and studies. This role also provides oversight and guidance to ensure high quality and timely deliverables. This person will have strong technical expertise, will be a collaborative team player and proactive problem solver. This position is an individual contributor and reports to the Head of Biostatistics.
Key Responsibilities :
- Provide strategic input to optimize trial designs in both early phase and late phase registrational studies
- Proactively collaborate with clinical trial team to support study conduct
- Provide oversight for external CRO to ensure timely deliverables
- Serve as statistical lead in support of IND / NDA / MAA or other regulatory submissions; provide thorough review for clinical documents, briefing books, and required components of regulatory submissions including appropriate datasets, define files, reviewer's guides, and other relevant documents
- Lead initiatives within Biostatistics function, and contribute to cross-functional process improvement efforts
- Perform QC of statistical deliverables including validation of key results
- Author or oversee the development of statistical analysis plans, statistical sections of protocols, and clinical study reports
- Stay updated with regulatory requirements and advanced statistical methodology and provide guidance to junior statisticians
- Conduct ad hoc analyses if needed
- Additional duties and responsibilities as required
Desired Experience / Education and Personal Attributes :
Location : Corporate office is in New York, NY. This position is a remote based opportunity.
Our client offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of the package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. The overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $230,000 - $260,000.