Senior Manager Biostatistical Programming
At a glance
Senior Data Science role at Amgen. Taipei · full-time.
Pay not stated Data Science salary
dataroles summary, based on the employer's posting.
What you'll do
- Lead the offshore programming team through study work and regulatory submissions for your assigned product areas
- Coordinate with the Global Programming Lead on worldwide programming approaches, including standards and industry requirements
- Track project progress, resolve delivery issues, and align staff use with product priorities
- Shape product-level resource and budget plans, and contribute to process improvement groups
- Support audits, maintain controlled GSP documents, and coach local programmers on their development
What you bring
- A quantitative or scientific degree, plus at least eight years of statistical programming in clinical development
- You have led programmers through complete study programming and built an offshore statistical programming team
- You bring SAS or R reporting skills, drug approval submission experience, and a strong grasp of data quality and compliance
- You have managed projects and staff development, and communicate in English across global teams
Who this fits
This senior leadership role suits someone who can guide an offshore team while also providing hands-on programming support when needed. You should be comfortable working across time zones and with globally distributed, cross-cultural teams.
From the employer
Career Category
Clinical DevelopmentJob Description
What you will do
Amgen is expanding its Global Statistical Programming (GSP) capabilities, with Amgen Taiwan playing a key role in supporting integrated delivery across regions. As a Senior Manager of Biostatistical Programming (Programming Execution Lead), you will partner with the Global Programming Lead (GPL) and lead an offshore team of Study Lead Programmers (SLP) and Study Programmers (SP) to ensure successful execution of end-to-end programming activities for products within or across therapeutic areas. Together with the GPL, this Senior Manager will be accountable and responsible for Global Statistical Programming study results and drug approval submission activities for the assigned product areas.
Key Responsibilities:
- Accountable and responsible for ensuring successful execution and delivery of Global Statistical Programming milestone analysis deliverables and regulatory submission packages for a product, or group of Amgen products, being supported by the offshore programming team.
- Work with GPL to ensure successful implementation of programming strategies, such as functional standards and industry requirements for the assigned product globally.
- Plan and monitor progress of projects and address issues accordingly.
- Provide GSP product level input to developing and managing resource plans and budgets for GSP.
- Efficiently and effectively monitor and utilize assigned staff at product level according to priorities.
- Lead and/or participate in departmental process improvement initiatives and cross-functional working groups.
- Assist in study and system audits and inspections by internal and external bodies.
- Develop, review, and implement Policies, SOPs and other controlled documents affecting GSP globally.
- Provide hands-on support to the assigned product areas as required.
- Provide coaching and mentoring to local programming staff.
- Provide input into career development plans for all staff on assigned projects
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a results-oriented, tech-forward programming leader with deep expertise in clinical trial operations and digital transformation.
Basic Qualifications:
- BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, with at least 8 years of statistical programming experience in clinical development environment.
- Strong technical, communication, and leadership skills
- Ability to lead and manage programmers in successful and timely completion of all programming activities for a study or multiple studies from end to end
- Experience developing a successful offshore statistical programming team
- Flexibility and desire to work across different time-zones
- Advanced analysis and reporting skills in SAS (including SAS/STAT, Macro, Graph, SQL, etc.) and/or R
- Prior regulatory submission experience for drug approval
- Thorough understanding and experience with data quality and compliance checks
- Experience in software development (e.g., gathering user requirements, creating technical specifications, developing code, creating, and driving test plans)
- Experience working effectively in a globally dispersed team environment with cross-cultural partners
- Prior staff development leadership and project management experience
- Excellent oral and written English communication skills
- Ability to effectively perform complex statistical programming and related tasks
Preferred Skills:
- MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative or scientific subjects
- Familiarity with open-source programming tools (e.g., R, Python), automation platforms, and emerging technologies in statistical programming
Thrive
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Data Science work from LinkedIn, X, Reddit and Upwork, in one list.
Each morning you get everything that fits, strongest first.
Data Science
Find me workBy the team behind dataroles.