Current jobs related to Director, Biostatistics - Boston, Massachusetts - Rhythm Pharmaceuticals
-
Head of Biostatistics
4 weeks ago
Boston, Massachusetts, United States Luminary Group Full timeBecome a Leader in Biostatistics at Luminary GroupWe invite you to consider a pivotal role as the Director of Biostatistics within our esteemed organization. In this capacity, you will spearhead our biostatistics and data management operations, ensuring that our clinical trial data is meticulously designed, analyzed, and reported to uphold the highest...
-
Biostatistics Team Leader
4 weeks ago
Boston, Massachusetts, United States Luminary Group Full timeBecome a Key Player as the Director of BiostatisticsLuminary Group is seeking an experienced Director of Biostatistics to spearhead our biostatistical and data management efforts. In this pivotal role, you will oversee the design, evaluation, and presentation of clinical trial data, ensuring adherence to quality standards and regulatory compliance.Key...
-
Head of Biostatistical Analysis
4 weeks ago
Boston, Massachusetts, United States Rhythm Pharmaceuticals Full timePosition OverviewCompany BackgroundRhythm Pharmaceuticals is a pioneering biopharmaceutical organization dedicated to enhancing the lives of individuals affected by rare neuroendocrine disorders. Our mission is to develop innovative therapies for conditions that have been historically neglected or inadequately addressed, while also providing substantial...
-
Head of Biostatistical Analysis
3 weeks ago
Boston, Massachusetts, United States Rhythm Pharmaceuticals Full timePosition OverviewCompany IntroductionRhythm Pharmaceuticals is a leading biopharmaceutical organization dedicated to improving the lives of individuals affected by rare neuroendocrine disorders. Our mission focuses on developing innovative therapies for conditions that have been historically overlooked or inadequately addressed, while also providing...
-
Boston, Massachusetts, United States Servier Full timeAbout ServierServier is a global pharmaceutical company with a strong presence in the US. We are committed to delivering innovative treatments for patients with unmet needs. Our team is dedicated to bringing the promise of tomorrow to those who need it most.Role Summary:We are seeking an Associate Director, Biostatistics Project Lead to join our team. This...
-
Head of Biostatistical Strategy
3 weeks ago
Boston, Massachusetts, United States Rhythm Pharmaceuticals Full timePosition OverviewCompany BackgroundRhythm Pharmaceuticals is a pioneering biopharmaceutical organization dedicated to enhancing the lives of individuals and their families affected by rare neuroendocrine disorders. Our mission is to create therapies for conditions that have historically been overlooked or inadequately addressed, while also offering...
-
Senior Biostatistics Project Lead
1 week ago
Boston, Massachusetts, United States Servier Full timeAbout ServierServier is a global pharmaceutical company dedicated to improving the lives of patients through innovative treatments. As a US-based affiliate, we are committed to delivering high-quality medicines and services to patients in need.Job SummaryWe are seeking an experienced Associate Director, Biostatistics Project Lead to join our team. In this...
-
Boston, Massachusetts, United States Harvard University Full timeJob SummaryWe are seeking an experienced Associate Director of Statistical Programming to join our team at the Center for Biostatistics in AIDS Research (CBAR) within the Harvard T.H. Chan School of Public Health in Boston, Massachusetts.Key ResponsibilitiesLead the development and implementation of statistical programming strategies and solutions to support...
-
Biometrics Director
1 week ago
Boston, Massachusetts, United States AL Solutions Full timeAL Solutions is seeking a Biometrics Leader to oversee the entire Biometrics unit and represent the company in front of regulatory agencies. The ideal candidate will have a strong background in Biometrics, leadership experience, and a deep understanding of FDA practices. Key responsibilities include overseeing Data Management, Statistical Programming, and...
-
Senior Biostatistician
4 weeks ago
Boston, Massachusetts, United States Mass General Brigham Full timeGENERAL SUMMARY:OVERVIEW STATEMENT:This role encompasses the statistical evaluation and programming for extensive international clinical studies. Ideal candidates will possess advanced formal education in statistics or biostatistics, with a focus on the design and analysis of both observational and experimental research, alongside robust statistical...
-
Biometrics Director
1 day ago
Boston, Massachusetts, United States AL Solutions Full time{"Job Summary": "70CD3A757EDepartment:Type: full time", "Requirements": "PhD or Master's in related field10+ years industry experienceStrong Leadership experienceSubmission experienceSound knowledge of FDA practices", "Job Description": "Biometrics Leadership OpportunityAL Solutions is seeking a Biometrics Leader to join our team. As a key member of our...
-
Biostatistician - Clinical Trials
2 days ago
Boston, Massachusetts, United States Mass General Brigham Full timeJob SummaryThis position involves statistical analysis and programming of large-scale international clinical trials. The successful candidate will have advanced formal training in statistics or biostatistics, including design and analysis of observational and experimental studies, and strong statistical computing skills.Key ResponsibilitiesCollaborate with...
-
Head of Real World Evidence Initiatives
4 weeks ago
Boston, Massachusetts, United States Vertex Full timeBecome a Key Player as the Director of Real World Evidence at VertexOverview:In the role of Director of Real World Evidence, you will collaborate closely with the Global Head of Real World Evidence, playing a crucial role in the development of comprehensive evaluations of real world data. Your main objective will be to analyze the natural course of diseases...
-
Professor of Biostatistics
3 days ago
Boston, United States Harvard T.H. Chan School of Public Health - Biostatistics Full timeThe Department seeks candidates for a faculty position at the level of full professor with tenure, who will take a leadership role in the department’s clinical trials and infectious disease research agendas as the director of the Center for Biostatistics in AIDS Research (CBAR). Candidates should have backgrounds in quantitative health sciences research...
-
Director of Biostatistics
3 months ago
Boston, United States Luminary Group Full timeJob DescriptionJob DescriptionLuminary Group is seeking a talented and experienced Biostatistics Director to join our client. As a Biometrics Manager, you will play a key role in leading and managing the biostatistics and data management functions within the company. You will be responsible for overseeing the design, analysis, and reporting of clinical trial...
-
Associate Director Biostatistics
4 weeks ago
Boston, United States GQR Full timePosition: Associate Director/Director, BiostatisticsLocation: Cambridge, MA (Onsite 2 days per week preferred), Remote (East Coast or CST) for exceptional candidatesCompany: A leading biopharmaceutical company (name withheld for confidentiality)Our client, a prominent biopharmaceutical company, is seeking a seasoned Associate Director or Director of...
-
Associate Director Biostatistics
4 weeks ago
Boston, United States GQR Full timePosition: Associate Director/Director, BiostatisticsLocation: Cambridge, MA (Onsite 2 days per week preferred), Remote (East Coast or CST) for exceptional candidatesCompany: A leading biopharmaceutical company (name withheld for confidentiality)Our client, a prominent biopharmaceutical company, is seeking a seasoned Associate Director or Director of...
-
Associate Director Biostatistics
3 weeks ago
boston, United States GQR Full timePosition: Associate Director/Director, BiostatisticsLocation: Cambridge, MA (Onsite 2 days per week preferred), Remote (East Coast or CST) for exceptional candidatesCompany: A leading biopharmaceutical company (name withheld for confidentiality)Our client, a prominent biopharmaceutical company, is seeking a seasoned Associate Director or Director of...
-
Executive Director, Biostatistics/Biometrics
1 month ago
Boston, United States Cornerstone Search Group Full timeLocationHybrid, Greater Boston Area, United States of AmericaExecutive Director, Biostatistics/Biometrics Stable and Growing Pharma, BostonOur client is an attractive Global Pharmaceutical Company located in Boston. They offer a very stable environment while also remaining smaller/more lean; allowing for creativity, flexibility, and visibility. They are...
-
Associate Director, Biostatistics
4 weeks ago
Boston, United States GQR Full timePosition: Associate Director, Biostatistics Key Responsibilities:Strategic Contribution:Influence development strategy by recommending innovative designs and decision-making tools.Select and approve statistical methods for clinical trials, ensuring accurate analysis and interpretation.Oversee and approve statistical sections in reports and regulatory...
-
Associate Director, Biostatistics
4 weeks ago
Boston, United States GQR Full timePosition: Associate Director, Biostatistics Key Responsibilities:Strategic Contribution:Influence development strategy by recommending innovative designs and decision-making tools.Select and approve statistical methods for clinical trials, ensuring accurate analysis and interpretation.Oversee and approve statistical sections in reports and regulatory...
-
Director / Sr. Director of Biostatistics
3 weeks ago
Boston, United States Softworld Inc Full timeJob Title: Sr. Director of Biostatistics Job Location: Boston MA 02215 Onsite Requirements: Late Phase Adaptive Design Oncology Job Description: Reporting to the Vice President, Biometrics you will be working with cross functional clinical teams responsible for statistical activities across client's clinical programs, including overseeing statistical...
-
Biostatistics, Associate Director
3 weeks ago
Boston, United States Luminary Group Full timeLuminary Group is seeking a talented and experienced Biostatistics Manager to join our client. As a Biometrics Manager, you will play a key role in leading and managing the biostatistics and data management functions within the company. You will be responsible for overseeing the design, analysis, and reporting of clinical trial data, ensuring high quality...
-
Director / Sr. Director of Biostatistics
1 month ago
Boston, United States Softworld, a Kelly Company Full timeJob Title: Sr. Director of BiostatisticsJob Location: Boston MA 02215Onsite Requirements:Late PhaseAdaptive DesignOncologyJob Description: Reporting to the Vice President, Biometrics you will be working with cross functional clinical teams responsible for statistical activities across client's clinical programs, including overseeing statistical deliverables...
-
Director / Sr. Director of Biostatistics
3 weeks ago
Boston, United States Softworld, a Kelly Company Full timeJob Title: Sr. Director of BiostatisticsJob Location: Boston MA 02215Onsite Requirements:Late PhaseAdaptive DesignOncologyJob Description: Reporting to the Vice President, Biometrics you will be working with cross functional clinical teams responsible for statistical activities across client's clinical programs, including overseeing statistical deliverables...
-
Director, Biostatistics
4 weeks ago
Boston, United States Entrada Therapeutics Full timeThe Organization What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the...
-
Associate Director, Biostatistics Project Lead
2 months ago
Boston, United States Servier Full timeAbout Servier With commercial stage products and a promising pipeline, we are a US-based affiliate of Servier Group, a unique global organization headquartered in France. Operating in more than 150 countries and governed by a non-profit foundation, we have multiple medicines approved in oncology, & other disease states globally. Additionally, we have...
-
Senior Director, Biostatistics
1 month ago
Boston, United States Vigil Neuroscience, Inc. Full timeJob DescriptionJob DescriptionVigil Neuroscience is the world's first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain's immune system. We are utilizing the tools of modern neuroscience drug development across...
-
Real World Statistics Associate Director
7 days ago
Boston, United States Vertex Pharmaceuticals Incorporated Full timeJob Description The Associate Director, Real World Statistics will overview and perform sophisticated scientific statistical analyses in support of the company's post-marketing areas for Global Medicines Development and Affairs (GMDA) and Commercial and Strategic Management (CSM), on new and complex issues with minimal guidance and mentoring. The Incumbent...
-
Real World Evidence Director
2 weeks ago
Boston, United States Vertex Pharmaceuticals Full timeReal World Evidence Director (Hybrid)Job DescriptionThe Real World Evidence Director leads the successful execution of studies in accordance with RWE, Disease area, Program and Enterprise goals as well as ensuring the reliable tracking and reporting of RWE studies, analyses and resource use. As an integral member of the RWE team, the RWE Director leverages...
-
Real World Evidence Director
2 weeks ago
Boston, United States Vertex Pharmaceuticals Full timeReal World Evidence Director (Hybrid)Job DescriptionThe Real World Evidence Director leads the successful execution of studies in accordance with RWE, Disease area, Program and Enterprise goals as well as ensuring the reliable tracking and reporting of RWE studies, analyses and resource use. As an integral member of the RWE team, the RWE Director leverages...
-
Real World Evidence Director
2 weeks ago
Boston, United States Vertex Pharmaceuticals Incorporated Full timeJob DescriptionThe Real World Evidence Director leads the successful execution of studies in accordance with RWE, Disease area, Program and Enterprise goals as well as ensuring the reliable tracking and reporting of RWE studies, analyses, and resource use. As an integral member of the RWE team, the RWE Director leverages subject matter expertise in their...
-
Real World Evidence Director
2 weeks ago
Boston, United States Vertex Pharmaceuticals Incorporated Full timeJob DescriptionThe Real World Evidence Director leads the successful execution of studies in accordance with RWE, Disease area, Program and Enterprise goals as well as ensuring the reliable tracking and reporting of RWE studies, analyses, and resource use. As an integral member of the RWE team, the RWE Director leverages subject matter expertise in their...
Director, Biostatistics
4 months ago
Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
Opportunity Overview
Rhythm is seeking a Director of Biostatistics to join our Biostatistics and Data Management team. Reporting to Vice President, Head of Biostatistics & Data Management, you will lead and provide strategic input from a biostatistics perspective and support all the statistical aspects for assigned clinical programs in a cross-functional and highly collaborative project team environment. You will be expected to be an independent statistical lead on projects. If you are a strategic thinker as well as a hands-on biostatistician who is committed to high standards of data integrity and quality, you will thrive in this role.
Responsibilities and Duties
- Provide strategic input and direction on the clinical development plans, innovative statistical design, sample size and power calculation, and responsible for statistical elements in protocol development, statistical analysis plans (SAPs) and TLFs, data analysis and statistical result interpretation.
- Work with project clinicians to design, develop, conduct, and analyze clinical protocols and statistical analysis plans.
- Prepare statistical related sections of protocol, clinical study reports, integrated summaries of safety/efficacy (ISS/ISE), etc. as needed.
- Proactively manage the vendors that conduct statistical work for Rhythm, validate and QC the statistical deliverables from vendors. Ensure accuracy, consistency, and quality output.
- Work closely with statistical programmers in dry-runs, QC of key efficacy and safety data, identifying data issues, etc.
- Support interim analysis plan, DSMB meetings, ad hoc analysis, etc.
- Help prepare the statistical components in regulatory submission packages (e.g., cCTD M2.5, M2.7 and M5 etc.).
- Support the clinical sections of INDs/NDAs/BLAs/MAAs to ensure proper presentation of statistical analyses and results.
- Support regulatory documents such as briefing book, and regulatory meeting as needed.
- Reviews CRFs, and work with data managers on DMPs, data edits check, etc.
- Contribute to the development and revision of statistics SOPs.
Qualifications and Skills
- MS or PhD degree (strongly preferred) in statistics or biostatistics
- At least 10 years biostatistical experience in pharmaceutical/biotech industry
- Ability to look broadly beyond biostatistics and contribute to integrated clinical, regulatory and safety discussions
- Ability to communicate concepts clearly and concisely verbally and in written form to broad audiences inside and outside the clinical team
- Strong basis in statistical concepts and expertise in statistical methodologies in clinical trials
- Strong statistical programming skills with SAS and R, experience with sample size software such as EAST
- Familiar with CDISC requirements for SDTM and ADaM
- Ability to work on multiple projects simultaneously
This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.
More about Rhythm
Our lead asset, IMCIVREE (setmelanotide), is a precision medicine designed to treat hyperphagia, an insatiable, pathological hunger characterized by abnormal food-seeking behaviors, and early- or rapid-onset severe obesity caused by an impairment of a pathway in the hypothalamus called the melanocortin-4 receptor (MC4R) pathway. IMCIVREE is the first and only approved therapy for certain rare MC4R pathway diseases in the United States, Europe, Great Britain and several other countries. In collaboration with leading experts across the world, Rhythm is advancing the most comprehensive clinical research program ever initiated in MC4R pathway diseases, including a Phase 3 trial for acquired hypothalamic obesity. In addition, we are leveraging our extensive genetic database, global network of researchers, a track record of regulatory successes and global commercial infrastructure to develop a full portfolio of treatment options to patients struggling with hyperphagia and severe obesity and ensuring they get the treatment that is right for them.
We continue to advance care and precision medicines that address rare diseases. We are focused on expanding access to IMCIVREE to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. Rhythm's headquarters is in Boston, MA.