Statistical Programming

5 days ago

Cambridge, United States Merus Full time
Statistical Programming (Senior Director - Executive Director)

Application Deadline: 28 February 2025

Department: Clinical Development

Employment Type: Full Time

Location: Cambridge, MA

Description

Statistical Programming (Senior Director - Executive Director)

This role is US based.

The team

You will be working in our Clinical Development department, providing strategic direction, team development and technical leadership. You will report to the Vice President Biometrics.

Key Responsibilities

The role

As the Executive Director, Statistical Programming, you will provide leadership and line management to Statistical Programming function, establish standards for statistical reporting, support resourcing, develop and maintain processes. Furthermore, your day-to-day tasks will include:
• Provide leadership and line management to Statistical Programming function, ensuring focus on business priorities and Merus' values.
• Ensure quality and timeliness of statistical analysis, reporting, and regulatory submission deliverables.
• Demonstrate strong technical expertise to promote best practices related programming environments, technology and programming skillsets.
• Establish and monitor effective and efficient resource sharing.
• Maintain strategy for capability and skill development to meet current and future requirements.
• Establish outsourcing strategies and execution of such strategies in support of business and financial objectives with accountability for functional budget.
• Maintain an environment to foster creativity and transparency, and a framework for continuous improvement.
• Drive standardization and innovation to ensure future fitness of the organization.

Skills, Knowledge and Expertise

Your profile

Required experience and skills:

- Advanced degree preferred. 15+ years of relevant work experience in biopharmaceutical industry and at least 5 years of experience managing a team.

- Track record of leading and overseeing global regulatory submissions in oncology.

- Superior knowledge and prior experience in setting strategy around the development of efficient analysis and reporting deliverables.

- Solid experience with reporting proceses, regulatory requirements, and software development life cycle.

- Strong leadership, interpersonal, and organizational skills, and ability to work within cross-functional teams.

- Strong project management skills.

- Strong communication skills with ability to align the company on complex technical decisions.

- Active coach and mentor whose goals are to grow and maximize the team's potential.

Benefits

Offer

We offer a once-in-a-lifetime opportunity to work with some of the best and brightest in the biotech industry. As part or Merus, you'll get to interact with a great international team of people who love what they do To top it all, we offer a competitive salary, flexible working hours and a company bonus structure. Most importantly, you'll have the chance to help us close in on cancer - everything you do matters at Merus.Learn More

  • Statistical Programming Consultant

    2 weeks ago

    Cambridge, United States Beacon Hill Life Sciences - Boston Full time

    Job DescriptionJob DescriptionResponsibilitiesReviews and validates CRO deliverablesOversees programming-related activities performed by CROSupports and manages regulatory compliant Clinical Data Repository and biometrics programming environmentWrites or reviews SAS programs to implement statistical analyses (i.e., generating tables, listings, figures, and...

  • Statistical Programming Director

    2 weeks ago

    Cambridge, Massachusetts, United States Takeda Full time

    Job SummaryWe are seeking a highly skilled Statistical Programming Director to lead our statistical programming activities across multiple studies and related oversight activities ensuring quality and timeliness.About the RoleThis is a leadership position that requires strong general knowledge of technical and programming methods, combined with applied...

  • Senior Statistical Lead

    2 weeks ago

    Cambridge, Massachusetts, United States Global Channel Management Full time

    About the job: Senior Statistical LeadThe ideal candidate will have 10 years of experience in Pharmaceutical/Biotech programming, with a focus on macro/tools development. This role requires strong SAS programming and statistical background skills, including expertise in SAS Base, SAS/Macros, SAS/Graph, and SAS/Stat. Additionally, experience with FDA...

  • Statistical Leadership Role for Pharmaceutical Sciences

    1 hour ago

    Cambridge, Massachusetts, United States Takeda Full time

    Are you passionate about leveraging statistical expertise to drive innovation in pharmaceutical sciences? Takeda is seeking a skilled Manager of Statistics to join our team in Cambridge, MA.About the RoleThis exciting opportunity will enable you to provide strategic statistical leadership in the design, analysis, and interpretation of CMC study data across...

  • Statistics Leadership Role in Pharmaceutical Sciences

    2 weeks ago

    Cambridge, Massachusetts, United States Takeda Full time

    About the OpportunityWe are seeking a highly skilled Manager of Statistics to join our Pharmaceutical Sciences team in Cambridge, MA.Job SummaryThis role will provide statistical leadership in the design, analysis, and interpretation of CMC study data throughout Pharmaceutical Sciences, promoting innovative design and analysis methodology.Key...

  • Statistical Leadership Expert for Curative Genome Editing

    2 weeks ago

    Cambridge, Massachusetts, United States Intellia Therapeutics Full time

    Imagine a workplace where innovation and determination drive you to excel and succeed together. At Intellia Therapeutics, we're pushing boundaries in genome editing treatments for severe diseases. As our Director Biostatistics, you'll be part of this mission, leveraging your expertise to positively transform lives.About the RoleProvide leadership and...

  • Senior Statistical Expert

    3 days ago

    Cambridge, Massachusetts, United States Intellia Therapeutics Full time

    About the RoleAs a Director Biostatistics and Analytics Lead, you will be part of our Clinical Development team at Intellia Therapeutics. We are looking for a seasoned professional with expertise in statistics, programming languages (SAS, R, or Python), and experience working in the Pharmaceutical/Biotechnology industry. This is a great opportunity to take...

  • Senior Programming Manager

    4 weeks ago

    Cambridge, United States Takeda Full time

    Takeda SQS is looking to add individuals to our team that are team oriented, collaborative, strong understanding of the statistical programming function, exceptional leaders and innovators. Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to...

  • Takeda | Senior Programming Manager | cambridge, ma

    4 weeks ago

    cambridge, United States Takeda Full time

    Takeda SQS is looking to add individuals to our team that are team oriented, collaborative, strong understanding of the statistical programming function, exceptional leaders and innovators. Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to...

  • Group Leader, Microbiome Program

    4 weeks ago

    cambridge, United States Broad Institute Full time

    General information Location Cambridge, MA Ref # 41346 Job Family Research Workplace On-Site Date published 15-Nov-2024 Time Type Full time Description & Requirements Job DescriptionThe Infectious Disease and Microbiome Program (IDMP) is looking for a Group Leader to leadand direct investigations into the mechanisms...

  • Group Leader, Microbiome Program

    1 week ago

    CAMBRIDGE, MA, United States Broad Institute Full time

    General information Location Cambridge, MA Ref # 41346 Job Family Research Workplace On-Site Date published 15-Nov-2024 Time Type Full time Description & Requirements Job DescriptionThe Infectious Disease and Microbiome Program (IDMP) is looking for a Group Leader to leadand direct investigations into the mechanisms...

  • AI and Decision-Making Professor

    2 weeks ago

    Cambridge, Massachusetts, United States Massachusetts Institute of Technology Full time

    Job Title: AI and Decision-Making ProfessorAbout the RoleWe are seeking an experienced professional to lead our Artificial Intelligence and Decision-Making (AI+D) MicroMasters program at Massachusetts Institute of Technology (MIT). The successful candidate will oversee the operation of the courses, develop educational content, and manage course materials.Key...

  • Senior Biostatistics Lead for Clinical Development

    2 weeks ago

    Cambridge, Massachusetts, United States Maxis Clinical Sciences Full time

    About the RoleAs a Senior Biostatistician at Maxis Clinical Sciences, you will be leading the statistical development strategy for our therapeutic antibodies. This is an exciting opportunity to leverage your expertise in drug development and biostatistics to drive innovation in clinical trials.Key ResponsibilitiesDevelop and implement statistical strategies...

  • Principal Biometrics Programmer

    1 day ago

    Cambridge, Massachusetts, United States Global Channel Management Full time

    About the Job: We are seeking an experienced Principal Biometrics Programmer to join our team at Global Channel Management. The ideal candidate will have a strong background in biometrics programming and a passion for delivering high-quality results.Key Responsibilities:Create CDISC SDTM and ADaM files, SAS export files, Define.xml, and Reviewer's Guide for...

  • Associate Director, Biostatistics

    4 weeks ago

    cambridge, United States Proclinical Staffing Full time

    Associate Director of Biostatistics - Permanent - Remote within USProclinical Staffing are partnered with a truly exciting Mid-Sized Global Pharma in their search for an Associate Director, Biostatistics. Primary Responsibilities:The business specialize across a diverse set of Rare Diseases with their work culminating in 9 products successfully approved and...

  • Associate Director, Biostatistics

    1 month ago

    Cambridge, United States Proclinical Staffing Full time

    Associate Director of Biostatistics - Permanent - Remote within USProclinical Staffing are partnered with a truly exciting Mid-Sized Global Pharma in their search for an Associate Director, Biostatistics. Primary Responsibilities:The business specialize across a diverse set of Rare Diseases with their work culminating in 9 products successfully approved and...

  • Associate Director, Biostatistics

    1 month ago

    Cambridge, United States Proclinical Staffing Full time

    Associate Director of Biostatistics - Permanent - Remote within USProclinical Staffing are partnered with a truly exciting Mid-Sized Global Pharma in their search for an Associate Director, Biostatistics. Primary Responsibilities:The business specialize across a diverse set of Rare Diseases with their work culminating in 9 products successfully approved and...

  • Associate Director, Biostatistics

    1 month ago

    cambridge, United States Proclinical Staffing Full time

    Associate Director of Biostatistics - Permanent - Remote within USProclinical Staffing are partnered with a truly exciting Mid-Sized Global Pharma in their search for an Associate Director, Biostatistics. Primary Responsibilities:The business specialize across a diverse set of Rare Diseases with their work culminating in 9 products successfully approved and...

  • Senior Data Analyst, Biomedical Informatics

    2 weeks ago

    Cambridge, Massachusetts, United States Repertoire Immune Medicines Full time

    About Repertoire Immune MedicinesRepertoire Immune Medicines is a pioneering biotechnology company dedicated to unlocking the vast potential of the human immune system for treating cancer and autoimmune diseases. Founded on the revolutionary concept that understanding the repertoire of T cell receptor (TCR)-antigen immune synapses holds the key to medical...

  • Associate Director Biostatistics

    1 day ago

    Cambridge, United States Hobson Prior Full time

    Hobson Prior is seeking a dedicated Associate Director of Biostatistics to guide the statistical aspects of early-stage clinical trials. The successful candidate will focus on designing trials, analysing data, and preparing information for regulatory purposes. This role involves collaboration with various stakeholders and managing outsourced activities, with...