Director, Global Submissions & Statistical Programming
TalentAlly
Biogen in Cambridge, MA seeks a Director of Statistical Programming to lead the Global Submissions group, shaping strategy and execution for global regulatory submissions across portfolios. You will allocate resources, align cross-functional plans, and maintain high-quality standards to advance development programs. The role requires deep regulatory knowledge, SAS expertise, and a track record of leading sponsor-side submissions. #J-18808-Ljbffr TalentAlly
$153.6k - $241.34k
...seeking an experienced leader in statistics and quantitative sciences to join a global, research-driven... ...disciplines—including statistics, programming, epidemiology, outcomes research... ...analysis plans, and regulatory submissions. Translate complex statistical findings...SuggestedTemporary workLocal areaImmediate start$181.1k - $244.9k
...The Associate Director, Statistical Programming is responsible for statistical programming activities in... ...programming deliverables for studies or for a submission. He/she ensures the team develops,... ...lead the creation and validation of global macros or systems that streamline...SuggestedFull timeTemporary workLocal areaFlexible hours$159k - $195k
...programmer to join us as Associate Director, Statistical Programming. This is a critical role responsible... ...support clinical trials, regulatory submissions, and other key initiatives. Required... ...Familiarity with ICH/GCP guidelines and global regulatory submission requirements (...SuggestedFull timeContract workLocal areaFlexible hours3 days per week$190.4k - $285.6k
## Director, Global Submission ManagementApplylocations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-29520**Job... ...global regulatory submissions across development and lifecycle programs. This role will manage submissions for development‐stage,...SuggestedSummer workRemote workFlexible hours2 days per week$172k - $258k
...Associate Director, Statistical Programming Company Overview Tango Therapeutics is a clinical-stage biotechnology company dedicated to discovering... ..., presentations, various reports for health authority submissions, clinical data review, and ad hoc analysis either...SuggestedFor contractors$172k - $258k
...Associate Director, Statistical Programming Tango Therapeutics is a clinical-stage biotechnology company dedicated to discovering novel drug targets... ..., presentations, various reports for health authority submissions, clinical data review, and ad hoc analysis either...- ...LinkedIn. Position Summary MBX is seeking an Associate Director, Statistical Programming to lead and contribute to statistical programming and... ...regulatory queries across multiple compounds and studies. Lead global submission activities, acting as a programming functional and...For contractorsWork at officeLocal area
$171.5k - $214.42k
Zenas is a clinical-stage global biopharmaceutical company committed... ...(MS). Zenas’ earlier stage programs include ZB021, a clinical-... ...Summary:The Associate Director, Statistical Programming will... ...study reports, and regulatory submissions. This role extends beyond study...Contract workFlexible hours$184.07k - $198.8k
...The Associate Director of Statistical Programming, as a member of the Biostatistics & Statistical Programming... ...and neurological disorders. A global biopharmaceutical company, headquartered... ...reporting. Experience with electronic FDA submission.Prefer proficiency in other data...Work at officeLocal areaFlexible hours3 days per week$160k - $275k
...Therapeutics is seeking an experienced and strategic Associate Director or Director of Statistical Programming to lead programming efforts for a compound-level... ...data requests. Support programming for regulatory submissions (e.g., Define-XML, ADRG/SDRG, eCTD) and provide...$200.7k - $271.5k
Overview: The Director, Technical Solutions will be responsible for... ...will oversee AWS-based programming and analytics platforms, drive... ...AWS cloud platform supporting Statistical Programming, Biostatistics,... ...people. We're proud to be a globally recognized top employer, wherean...Full timeTemporary workLocal areaFlexible hours- ...Rapport Therapeutics seeks a Senior Manager/Associate Director of Statistical Programming to lead clinical trial programming activities across the... ...development through clinical study reports and regulatory submissions Develop, validate, and document SAS programs for...
- ...Tango Therapeutics seeks an Associate Director of Statistical Programming to lead clinical trial programming activities, manage analysis datasets and regulatory submissions, and oversee statistical computing infrastructure. The role reports to the Senior Director and...
- ...Title:Director, Biostatistics Company:Ipsen Biopharmaceuticals... ...: Ipsen is a mid-sized global biopharmaceutical company... ...for providing program and project-level statistical expertise and leadership... ...publications, and regulatory submission documents. Provide strategic...
$236k - $274k
...is seeking an experienced Director of Biostatistics to lead statistical activities supporting our oncology clinical programs. This individual will... ...experience supporting regulatory submissions and interactions is... ...Founded in 2020, we've built a global team of over 100...Full timeTemporary workWork at officeLocal area3 days per week$289.9k - $307.7k
...Senior Director, Biostatistics - Solid Biosciences... ...Biostatistics to provide statistical leadership across its... ...statistician for one or more programs and guide statistical... ...through regulatory submission. Reporting to the... ...statistical strategies for global health authority...Temporary workInterim roleRemote workFlexible hours$212.5k - $287.5k
...Director, Biostatistics The Director, Biostatistics... ...clinical development program(s). He/she is responsible for statistical activities including: designing... ...support of regulatory submissions as well as manuscripts,... .... We're proud to be a globally recognized top employer...Full timeTemporary workLocal areaWorldwideFlexible hours- ...to apply for the Senior Director, Biostatistics role at... ...responsible for leading the statistical activities for 1 or more clinical programs, providing strategic... ...during regulatory submissions, serving as the primary... ...preparing and participating in global regulatory agency...Full timeLocal areaRemote work
$244.99k - $296.87k
...Director, Biostatistics At Bristol Myers Squibb... ...Clinical Development Plans, submissions, and post-submission... ..., and oversees the statistical support for the... ...and SOPs, adherence to global and project standards... ...scientific computing/programming (SAS, R or Python) and...Hourly payFull timeSummer workLive inLocal areaRemote workFlexible hours$210k - $300k
...Overview Rhythm is a global, commercial-stage... ...Rhythm is seeking a Senior Director, Biostatistics to join... ...clinical development programs. This individual will... ...opportunity to shape statistical strategy for programs... ...and efficacy, and other submission-related materials....Interim roleWork at officeFlexible hoursShift work$270k - $290k
...Sr. Director of Biostatistics Atavistik Bio is a privately-held clinical... ...you will be acting as the statistical lead for one program or multiple programs, providing... ...Key contributor on regulatory submissions and communication with global regulatory authorities Provide...Interim roleRemote workFlexible hours$218.12k - $264.31k
...Associate Director, Biostatistics Working with Us... ...benefits, services and programs that provide our employees... ...of regulatory submissions. With appropriate experience... .../or reviews protocol, statistical analysis plan,... ...and SOPs, adherence to global and project standards...Hourly payFull timeTemporary workPart timeFor contractorsSummer workWork at officeRemote workFlexible hoursShift work$200k - $213k
...Clinical Development, Regulatory Agency submissions and Medical Affairs activities. Job... ...mining. Tasks include planning, programming, and executing statistical analyses; contributing to content... ...psychiatric and neurological disorders. A global biopharmaceutical company,...Work at officeLocal areaFlexible hoursNight shift3 days per week- ...significant unmet need. The company’s lead program, DMR-001, is an investigational... ...pipeline. Position Summary The Associate Director, Statistical Programming serves as the programming... ...deliverables from study start-up through submission. The Associate Director provides hands...For contractors
$155k - $225k
...critical unmet need. As a global leader in myostatin... ...anti-myostatin program, including opportunities... ...experience in clinical statistics to join our team. The... ...Senior Manager/Associate Director, Biostatistics will participate... ...design to regulatory submission. The Biostatistics...- ...Kymera Therapeutics seeks an experienced Associate Director or Director of Statistical Programming to lead programming efforts across multiple clinical... ...blind periods with PK/PD function Support regulatory submissions including Define-XML, ADRG, SDRG, and eCTD...
$230k
Overview The Director of Biostatistics is a hands‑on statistical leader responsible for the design, analysis, and interpretation... ...of outsourced biostatistics and programming activities Actively review... ...directly to regulatory submissions, briefing documents, and...Full timeInterim roleFlexible hours$191.2k - $286.8k
...new role, reporting to the Senior Director, Biometrics you will be working... ...clinical teams responsible for statistical activities across Tango’s clinical programs, including overseeing statistical... ...IND/NDA/MAA or other regulatory submissions; provide thorough review for...$206k - $257.5k
...and are building a robust portfolio of programs across muscle, central nervous system,... ...Statistician, taking ownership of the statistical strategy and execution for assigned clinical... ..., statistical analysis, regulatory submissions, and direct interaction with cross-functional...Full timeInterim role- ...The Director of Biostatistics will lead the statistical strategy, design, and trial-level execution for early-phase... ...cohort expansion models. Analysis & Programming: Program, validate, and perform... ...and accuracy. Regulatory Submissions: Prepare data packages and statistical...
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