Director Biostatistics

Career Category

Clinical

Job Description

Join Amgens Mission of Serving Patients

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. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. 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.

Accountabilities

Develop lead and serve as the primary point of contact for the statistical program strategy for a portfolio of complex programs

Influence across product life cycle through developing statistically compelling Evidence Generation Plans (EGP) in collaboration with Strategic Development Director Director Statistical Innovation EDL GDL GMAL and Regional Medical Leads

Partner with evidence-related cross-functional stakeholders to ensure the highest statistical standards and integrity and provide program level statistical support

Responsibilities

Statistical Excellence

Understand promote and communicate innovative and standard statistical methodologies trial design data analysis and me dical / clinical understanding for product

Partner with CfDA Design & Innovation to drive novel designs and fit-for-purpose statistical approaches standards technical quality study design analysis interpretation and evidence synthesis in balance with speed quality and cost for designated products / programs

Partner with Strategic Development Director / Director Statistical Innovation / EDL / GDL / GMAL / PT to define the data and evidence requirements for product lifecycle and translate it into the EGP as well as other potential applications of innovations (e.g. collaborations with CfOR and HEOR)

Oversee creation of Global Statistical Strategic Plan (GSSP) to align program design and statistical approaches with product strategy and EGP

Oversee statistical contributions to key design elements protocols randomization specifications statistical analysis plans tables figures and listings shells submission data file specifications and other key product-related documentation

Partner with evidence-related cross-functional stakeholders to ensure the highest statistical standards and integrity and provide program level statistical support for HTAs and payer negotiations regulatory submissions RTQs safety and benefit-risk assessment and scientific publications

Provide strategic input and be the key biostatistics contact for regulatory queries and interactions with regulatory agencies in collaboration with the Principal Statistician

Contribute to statistical strategy with other analytical groups (e.g. PK / PD modelling strategy biomarker analysis plan)

Resource Management

Lead global biostatistics team

Lead in the achievement of annual department goals

Manage and develop staff

Ensure Biostatistics team effectively utilize assigned supplier resources

Oversee development of Amgen Policies SOPs and other controlled documents

Basic Qualifications

Doctorate in Statistics / Biostatistics and post-graduate statistical experience in the pharmaceutical industry or medical research and

At least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Or

Masters degree in Statistics / Biostatistics or related subject with high statistical content and

At least 10 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Preferred Qualifications

Doctorate in Statistics / Biostatistics and 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research in Oncology / Hematology therapy area of at least 4 years

Or

Masters degree and 12 years of Biostatistics experience in the pharmaceutical industry or medical research in Oncology / Hematology therapy area of at least 4 years

What you can expect of us

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 San Francisco is $240284 - $280634 . 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 including remote and hybrid work arrangements where possible

Apply now and make a lasting impact with the Amgen team.

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.

Application deadline

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.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse 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 and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

217725.00 USD - 246888.00 USD

Required Experience :

Director

Key Skills

Fundraising,Management Experience,Coaching,Analysis Skills,Strategic Planning,Team Management,Budgeting,Leadership Experience,Mentoring,Public Speaking,negotiation,Supervising Experience

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 246888 - 246888