Amgen logo
Amgen

#WeareBiotech

Director, Centralized Statistical Monitoring

DirectorDirectorFull TimeRemoteLeadTeam 10,001+Since 1980H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

3 days ago

Salary

$200.1K - $270.7K / year

Seniority

Lead

Postgraduate Degree8 yrs expEnglishPythonSDLC

Job Description

Director, Centralized Statistical Monitoring

Amgen

• Provide strategic, statistical, technical, operational, and business leadership for Centralized Statistical Monitoring (CSM). • Accountable for the CSM analysis system, signal framework, statistical methodology, team leadership, cross-functional delivery, and continued evolution of CSM as part of Amgen’s broader Risk-Based Quality Management (RBQM). • Lead CSM capability development across a growing clinical portfolio, ensuring that CSM remains scientifically rigorous, scalable, inspection-ready, and aligned with portfolio, regulatory, study team, and business needs. • Serve as the business owner for Amgen’s CSM analysis system, signal framework, and analytical workflows. • Lead the strategy, roadmap, operating model, and continued evolution of the CSM capability in partnership with the Head of CSM / CfDA Safety and cross-functional stakeholders. • Provide leadership and accountability for the CSM Statistics team and statistical deliverables supporting the CSM capability. • Advance conventional and innovative CSM methodology to support RBQM, Quality by Design, data quality, data integrity, and clinical study quality oversight. • Prioritize CSM system enhancements, signal development, automation opportunities, and related RBQM analytical needs, including QTL approaches where aligned with CSM scope and portfolio priorities. • Lead governance, documentation, inspection readiness, lifecycle management, and long-term sustainability of the CSM capability. • Serve as a senior point of accountability for CSM-related questions, escalations, study team support, and cross-functional alignment. • Lead, coach, and develop CSM statisticians and supporting resources. Direct line management responsibilities may be in scope depending on the final operating model.

Job Requirements

  • Doctorate degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 8 years of relevant experience OR Master's degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 12 years of relevant experience
  • Significant statistical experience in the biopharmaceutical industry, including clinical development and clinical trial statistical oversight.
  • Experience with Centralized Statistical Monitoring, RBQM, QTLs, Quality by Design, data integrity, or clinical trial quality oversight.
  • Experience developing, evaluating, validating, or implementing statistical monitoring signals or regulated analytical deliverables in a production environment.
  • Experience serving as a business owner, product owner, capability lead, or functional owner for an analytical, statistical, or clinical system, including SDLC activities such as requirements, UAT, business validation, release readiness, documentation, and lifecycle management.
  • Strong statistical programming and analytical skills using SAS and/or R; Python experience a plus, with experience working with clinical trial, operational, EDC, metadata, or external data sources.
  • Familiarity with Bayesian methods, hierarchical modeling, machine learning, advanced analytics, R Shiny, or business intelligence platforms.
  • People management, functional leadership, coaching, or matrix leadership experience, including leading cross-functional initiatives.
  • Strong communication skills, global collaboration skills, and understanding of regulatory and industry trends relevant to RBQM, clinical trial quality, data integrity, and centralized monitoring.

Benefits

  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
  • Group medical, dental and vision coverage
  • Life and disability insurance
  • Flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible.

Related Categories

Related Job Pages

More Director Jobs

Celestica logo

Director, Customer Business Unit – 1

Celestica

Unlock the Potential of the Future

Director3 days ago
Full TimeRemoteTeam 10,001+Since 1994H1B Sponsor

• The Global Business Unit Director is responsible for supporting a team of multiple global program managers/Customer Focus Team leads for a large hyperscale customer strategic account in our growing Connectivity and Cloud Solutions business. • Provides collaborative support to Sales and Business Development for new and competitive business quotes for manufacturing, product solutions, repair, or design services. • Interface with the Technical Director of the GCBU regarding technical issues and design projects. • Act as an executive interface on commercial areas & operates within the objectives set by the Division. • Provides direct & indirect supervision to all subordinate staff involved in supporting each customer under the director’s ownership. • Responsible for contract and commercial management, account profitability, financial performance, and overall Customer Satisfaction. • Oversee pricing and quoting activities from Sales, SCM, Quoting, and CFT.

New Hampshire
4D Molecular Therapeutics logo

Executive Director, IP

4D Molecular Therapeutics

Powering the Future of Genetic Medicines

Director3 days ago
Full TimeRemoteTeam 51-200H1B Sponsor

• Develop and refine intellectual property strategy for 4DMT products and platforms; present IP strategy updates to executive leadership, as needed. • Responsible for implementing key elements of 4DMT’s intellectual property strategy, and managing its patent, trade secret, and trademark portfolio; implements a strategy for IP lifecycle management. • Directs outside counsel in the preparation and prosecution of applications and responding to office actions; directs outside counsel in evaluating the patentability of invention submissions and registrability of trademarks globally; manages related outside counsel budgets. • Identifies strategic areas for patenting, trade secret protection, and trademarking; collaborates with R&D, CMC, Clinical Science, and other functions to proactively identify and develop patentable intellectual property to prepare, file, and prosecute. • Manages patentability, freedom-to-operate, infringement, validity, and regulatory exclusivity analyses. • Supports and manage IP disputes and administrative proceedings, including oppositions and post-grant challenges. • Identifies and tracks 4DMT trade secrets and provides counsel with respect to 4DMT’s trade secret protection practices. • Provides IP perspective and counseling at 4DMT meetings and presents on IP topics. • Counsels and trains internal clients on intellectual property practices and policies. • Conducts IP due diligence for business development activities and supports IP due diligence related to financing activities. • Drafts, reviews, and negotiates agreements to support R&D and CMC activities, including NDAs, MTAs, MSAs, sponsored research agreements, consulting agreements, and licenses. • Collaborates with Legal colleagues, Business Development, and other key leaders and functions on key strategic agreements, including licenses, collaboration agreements, and other business development efforts. • Assists with other Legal Department matters, including litigation support, SEC reporting (IP-related sections), records management, compliance activities, and template projects. • Other duties as assigned; nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

United States
$309K - $350K / year

Role Description This is the creative heart of the Anime Studio. As Lead Anime Director, you are not coming in to execute someone else's vision. You are coming in to lead ours, and help build it from the ground up. We are looking for someone who has actually been leading anime production, who knows what a full pipeline looks like end to end, and who is genuinely excited by the idea of doing it differently. This is a rare opportunity to have real creative authority at a studio that is still early enough that your fingerprints will be on everything we make. What You'll Do - Direct the full animation pipeline from storyboarding and animatics through final composition and post-production - Set and maintain the visual quality standard for every series we produce - Deeply understand the source material we are adapting, manga, manhwa, and webcomics, and make smart, exciting calls on how to bring them to life as anime - Ensure strong character acting, fluid movement, cinematic staging, and consistent art direction across episodes - Build, manage, and give feedback to a remote team of key animators, background artists, compositors, and other production artists - Collaborate with producers and writers to translate scripts into compelling visual storytelling - Establish efficient workflows for our fully remote, globally distributed team - Create style guides, standards, and reference documents that allow the team to scale without losing quality - Oversee SFX, voice direction, and music coordination, stepping in where needed to keep productions moving - Work directly with indie manga and webcomic creators throughout the adaptation process - Proactively surface things a first-time studio might not think to ask about, and bring those to the table before they become problems Qualifications - Proven experience as an Animation Director, Episode Director, Series Director, Lead Key Animator, or similar senior role on high-quality 2D animation or anime-style projects - Strong portfolio or showreel showing animation direction, storyboarding, visual storytelling, and technical animation ability - Deep understanding of professional 2D animation pipelines from storyboard to final composition - Working knowledge of tools such as Clip Studio Paint, TVPaint, Toon Boom Harmony, After Effects, or similar production software - Deep knowledge of anime, manga, manhwa, and webcomic culture, not just familiarity, but genuine enthusiasm for these communities and the stories they tell - Ability to lead, critique, and organize a fully remote creative team with clarity and consistency - Experience working with or directing SFX, voice production, and music coordination - Strong communicator who can work with indie creators, a small internal team, and contractors without losing the creative thread - Highly organized with the ability to manage multiple productions at different stages simultaneously - Available at least 5 days per week and comfortable in a fully remote, output-focused environment Benefits - Fully remote work - Pay raises and bonuses for strong performance - Long-term role with full-time potential - Work with a growing e-commerce brand in a fun anime-inspired industry with a strong niche audience - Role-specific opportunity: Lead the visual direction, animation standards, and remote production systems for an original anime IP from the ground up

Worldwide
Multiplier Technologies Private Limited logo

Director/Sr Manager, Referral Partnerships

Multiplier Technologies Private Limited

We are Multiplier! Our global (digital) employment platform empowers companies to build and manage a distributed workforce, while tackling the complexities of local labour laws, employee contracting, payroll, benefits, and taxes. We’re on a mission to impact economies of scale and disrupt the incumbents within the employer of record (EOR) space. We’re Series B funded and backed by some of the best in the game (i.e. Sequoia and Tiger Global), led by domain-level experts, scaling massively, and seeking brilliant, like-minded enthusiasts to join our team.

Director3 days ago
Full TimeRemoteTeam 201-500

Role Description We are seeking a Director/Senior Manager, Referral Partnerships to take full ownership of Multiplier’s affiliate and referral channels. This is not a standard "coupon code" affiliate role; this is a strategic B2B position. You will be responsible for recruiting, managing, and scaling relationships with high-value publishers, HR consultants, B2B influencers, and SaaS review platforms. Your goal is to turn the affiliate channel into a significant, predictable engine for Monthly Recurring Revenue (MRR). Key Responsibilities - Strategy & Program Management - Own the Roadmap: Develop and execute a comprehensive global affiliate strategy aligned with Multiplier’s revenue goals. - Commission Structure: Design and optimize competitive commission models (CPA, RevShare, Hybrid) that maximize ROI while motivating partners. - Budgeting: Manage the affiliate budget, ensuring efficient CAC (Customer Acquisition Cost) and LTV (Lifetime Value) alignment. - Platform Management: Serve as the primary admin for our PRM (Partner Relationship Management) software, ensuring accurate tracking and attribution. - Partner Recruitment & Acquisition - Proactive Scouting: Identify and recruit high-quality B2B partners, including HR tech publications, business consultants, VC firms, and industry thought leaders. - Outbound Campaigns: Execute targeted outbound campaigns to onboard new high-traffic partners in key regions (APAC, EMEA, US). - Negotiation: Lead contract negotiations to secure premium placements and exclusive opportunities with top-tier publishers. - Activation & Enablement - Onboarding: Create a seamless onboarding experience that gets partners active and promoting Multiplier within their first 30 days. - Asset Creation: Collaborate with the Content and Design teams to provide partners with high-converting collateral (banners, landing pages, email swipes, and case studies). - Webinars & Education: Host webinars or training sessions to educate partners on Multiplier’s USP, ensuring they sell our solution accurately. - Optimization & Reporting - Data Analysis: Deep dive into partner performance data. Identify dormant partners to reactivate and top performers to scale. - Conversion Optimization: Work with the CRO team to optimize affiliate landing pages to improve click-to-lead conversion rates. - Fraud Prevention: Monitor traffic quality and flag suspicious activity or compliance violations. - Reporting: Present granular reports on Leads, SQLs, Closed-Won Revenue, and Payouts to executive leadership. Qualifications - 5+ years in Affiliate Marketing or Partnerships, with at least 3 years in B2B SaaS. - Proven history of scaling an affiliate program from early stages to significant revenue contribution. - Deep proficiency with affiliate platforms (PartnerStack, Impact, TUNE) and CRM tools (HubSpot/Salesforce). - Existing relationships with B2B publishers, HR and Finance influencers, or SaaS review sites (G2, Capterra) is a massive plus. - Exceptional written and verbal communication skills in English. Who You Are - You understand that selling a high-value B2B SaaS product is different from e-commerce. - You are empathetic and persuasive. Partners love working with you because you help them make money. - You don't guess; you test. You are comfortable with Excel/Sheets, pivot tables, and analytics tools. - You thrive in remote environments and don’t need to be micromanaged.

Worldwide