Biostatistical Programming Sr Mgr

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease obesity and obesity-related conditions rare diseases inflammatory conditions and cancer. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.

Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Biostatistical Programming Sr Mgr

Lets do this. Lets change the this vital role you will work in Amgens Biosimilar organization supporting multiple products.

• Represent the product programming function and participate in multidisciplinary project team meetings;
• Collaborate closely with Biosimilar Statisticians and other functional team members;

• Coordinate and oversee the development of dataset specifications and implementation of TLGs according to the statistical analysis plans work practices and project timelines in close partnership with CROs in a full-service CRO model;
• Review and approve analysis dataset specifications;
• Review or contribute to data management plans database development and edit checks plan;
• Contribute to and review the statistical analysis plans; and results presented in IBs protocols clinical study reports integrated summaries of safety/efficacy publications and other documents as required; provide support and input in protocol development case report form design and data collection;
• Ensure that statistical outputs datasets and related documentation are archived in a clear organized and timely fashion according to company standards;
• Proactively anticipate and communicate resource and quality issues that may impact deliverables or timelines within functional area as well as cross-functionally;

• Participate in the review of CRO Policies SOPs and other controlled document development;
• Participate in the recruitment of programming staff within Biosimilar organization;
• Operational effectiveness Recommendations for Program Level Consistency and Submission Readiness including data standards;
• Work with CRO and Amgen team to put together the submission data packages;
• Lead and/or contribute to the technical solutions to execute CRO programs on Amgen system and perform ad-hoc analysis to support submission and publications need;
• Lead and/or Contribute to process improvement and operational efficiency;
• Adhere to Amgen Policies Standard operation procedures (SOPs) and other standards which are applicable to biosimilar development.

We are all different yet we all use our unique contributions to serve patients. The professional we seek is a Biostatistical Programming Sr Mgr with these qualifications.

Basic Qualifications:

• BA/BSc or higher degree in quantitative or scientific subjects
• At least 8 years of relevant statistical programming experience in a clinical development environment
• Excellent oral and written English communication skills
• Experience working effectively in a cross-functional team environment
• Advanced SAS programming skills in processing clinical data (SAS - BASE STAT Macro and Graph)
• Working knowledge of latest CDISC SDTM ADaM and Define-XML standards
• Ability to lead and manage programmers in the successful and timely completion of all programming activities for a project
• Ability to effectively perform complex statistical programming and related tasks

Preferred Qualifications

• MSc or higher degree in quantitative or scientific subjects
• Familiarity with other programming languages (e.g. Java R)
• In depth knowledge of SAS Graph SAS STAT SAS Macro and SQL
• Regulatory submissions experience
• Thorough understanding and experience with data quality and compliance checks e.g. Pinnacle21
• Experience of working within a global team and CRO partners to ensure operational excellence and efficiencies.
• Prior staff development and project management experience
• Ability to train others

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities that may include:

• 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 and 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. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race color religion sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities consistent with legal requirements. Please contact us to request accommodation.

Salary Range