Associate Director/Director, Biostatistician
4 weeks ago
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.
-
Senior Biostatistician
4 weeks ago
Boston, Massachusetts, United States OM1 Full timeOM1 is on a mission to improve health outcomes by unlocking the power of data. We are a healthcare data and technology company focused on real world clinical data and outcomes, accelerating medical research and personalizing healthcare. Our interdisciplinary team uses expertise in medicine, software, Big Data, machine learning, public health and mathematics...
-
Associate Director
21 hours ago
Boston, United States S&P Global Full timeAnd Impact: Lead and mentor a talented team of software engineers, fostering a culture of collaboration, innovation, and continuous learning. Drive the development and execution of strategic initiatives to enhance software engineering processes and p Director, Associate, Software Engineer, Computer Science, Practice, Technology
-
Associate Director
1 week ago
Boston, MA, United States Linesight Full timeAssociate DirectorAs an Associate Director at Linesight, you will lead highly experienced, culturally diverse, and passionate teams nurturing a strong social dynamic and a shared sense of achievement. You will build on your vast industry experience which will open doors for you, extend your skillset and expand your perspective. We will empower, support, and...
-
Associate Director, Annual Giving
2 days ago
Boston, United States Emerson College Full timeReporting to the Director, Annual Giving, the Associate Director, Annual Giving executes the overall strategy and provides management and leadership for segmentation and execution of annual giving direct mail campaigns, digital communications, and th Director, Associate, Communication, Skills, Marketing, Project Management, Education, Business Services
-
Associate Director, Research F
4 weeks ago
Boston, United States Harvard University Full timeOne of the School's top priorities is unleashing intellectually ambitious research, and the Associate Director, Research Funding and Business Operations will serve as a member of a tightly integrated leadership team in the Division of Research and Faculty Development (DRFD) with a focus on this priority; ensuring that Harvard Business School (HBS) faculty...
-
Project Director
1 week ago
Boston, MA, United States Mass General Brigham Full timeDescriptionBipolar Disorder Learning Health Network Project DirectorJob Description:The Bipolar Disorder Learning Health Network’s (BD LHN) mission is to ensure that every person living with bipolar disorder is part of a system that reduces morbidity and improves the health and well-being of people with bipolar disorder. The Network will bring together a...
-
Associate Director
4 days ago
Boston, Massachusetts, United States Proclinical Staffing Full timeAssociate Director, Digital Strategy - Permanent - Boston, MAProclinical is seeking a dynamic leader to spearhead the North America's digital strategy and implementation roadmap. This is a permanent position located in Boston, MA.Primary Responsibilities:This role is pivotal in aligning digital capabilities, data, and solutions with business objectives and...
-
Associate Director, Payroll
16 hours ago
Boston, Massachusetts, United States Arrowstreet Capital Full timeJob Overview We are a high growth, fast-paced firm looking for a Payroll Associate Director to join our Finance & Administration Department. This position sits under the CFO reporting into the Payroll Director. The Payroll Associate Director will be part of the team responsible for processing payroll, related reporting and data integrity. This is a highly...
-
Associate Director, Payroll
9 hours ago
Boston, United States Arrowstreet Capital Full timeJob Overview We are a high growth, fast-paced firm looking for a Payroll Associate Director to join our Finance & Administration Department. This position sits under the CFO reporting into the Payroll Director. The Payroll Associate Director will be part of the team responsible for processing payroll, related reporting and data integrity. This is a highly...
-
Associate Director, Clinical Pharmacology
4 weeks ago
Boston, Massachusetts, United States Fusionpharma Full timeAssociate Director, Clinical Pharmacology/DMPK Management Boston, MA, USFusion is looking for an Associate Director, Clinical Pharmacology/ DMPK to join non-clinical development group.The successful candidate must have experience and foundational knowledge and experience in clinical pharmacology, drug metabolism, pharmacokinetics, bioanalytical and PK/PD...
-
Associate Director of Account Management
24 hours ago
Boston, United States Mondo Full timeApply now: Associate Director, Account Management location is Boston, MA. The start date is ASAP for this full-time permanent position Job Title: Associate Director, Account Management Location-Type: Boston, MA Onsite 2-4x a month Start Date Is: ASAP Duration: FTE Permanent Compensation Range: $120-145K Job Description: Must Haves 7+ years of performance...
-
Associate Director of Account Management
24 hours ago
Boston, United States Mondo Staffing Full timeApply now: Associate Director, Account Management location is Boston, MA. The start date is ASAP for this full-time permanent position Job Title: Associate Director, Account Management Location-Type: Boston, MA Onsite 2-4x a month Start Date Is: ASAP Duration: FTE Permanent Compensation Range: $120-145K Job Description: Must Haves 7+ years of performance...
-
Associate Director, Human Resources
7 days ago
Boston, United States Boston Public Health Commission Full timeThe Mission The mission of the Boston Public Health Commission (BPHC) to work in partnership with communities to protect and promote the health and well-being of all Boston residents, especially those impacted by racism and systemic inequities. The B Director, Human Resource, Associate, Public Health, Business Partner, Support, Administrative, Healthcare
-
Boston, United States Boston Medical Center Full timeThe Associate Director of Financial Reporting will assist in effectively meeting company objectives by working with the Company's external audit and tax advisors on external filings, submissions and other external financial reporting matters. Additionally, the Associate Director will lead the internal financial reporting efforts specific to month-end close...
-
Podiatrist
12 hours ago
n/a, MA, United States Medical Director Services PC Full timeMedical Director Services PC is looking to hire experienced Podiatrist s to service our skilled nursing facilities throughout Massachusetts. Inquire about availability in other states as well! Now Offering a Sign-On Bonus! Summary: Provide professional and medical podiatric services to patients with conditions affecting the foot, ankle, and...
-
Executive Director
6 days ago
Boston, United States Joseph Nee South Boston Collaborative Center Full time**Description**: The Joseph Nee South Boston Collaborative Center is a community-based Non-Profit with a mission to create a safe and welcoming environment providing substance use and mental health counseling services in an outpatient setting serving the Greater Boston Community. The Joseph Nee South Boston Collaborative Center goal is to improve and enhance...
-
Director/Assoc Director Regulatory Affairs
4 weeks ago
Boston, United States Apex Systems Full timeJob#: 2025096 Job Description: Associate Director/Director, Regulatory Affairs 2025096 Location: Boston, MA(Remote) Therapeutic Areas : Neuro Job Overview: The Associate Director/Director will develop and implement global regulatory strategies, serving as the regulatory lead for clinical studies and obtaining necessary approvals for initiation,...
-
Program Director BWH Cardiovascular
1 week ago
Boston, MA, United States Mass General Brigham Full timeDescriptionThe Cardiac Imaging Core Lab (CICL) is an academic research organization located within the Brigham and Women’s Hospital, a Harvard-affiliated hospital. The CICL provides echocardiography core laboratory services for primarily large-scale global clinical trials responsible for site training and interface as well as echo analysis of images...
-
Associate Director of Programs
3 weeks ago
Boston, United States Toyota of Redlands Full timeSince 1899, the Boston Rescue Mission (BRM) has focused on preventing and ending homelessness and in guiding people from a place of need to a place of self-sufficiency. Located in the heart of downtown Boston, BRM serves women and men who are homeless and at risk of homelessness 365 days a year. People in crisis, including veterans, come to the Mission to...
-
Associate Director/Site Manager
2 weeks ago
Boston, United States Pharmaceutical Company Full timeAssociate Director/Site Manager/Cloud Infrastructure, International Pharma Company, 185k plus bonus, BostonHYBRID MODEL3 DAYS ON SITEMUST MANAGE MULTIPLE SITES AND HAVE PHARMA GXP BACKGROUNDMUST BE A US CITIZEN OR GREEN CARD HOLDERThe Associate Director, Infrastructure Site Lead is responsible for overseeing all IT infrastructure operations at the designated...