What are the responsibilities and job description for the Biostatistics Director position at Initial Therapeutics, Inc.?
Join Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's 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, you'll 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, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Biostatistics Director
What you will do
Let's do this. Let's change the world. In this vital role, you will 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
- Understand, promote, and communicate innovative and standard statistical methodologies, trial design, data analysis, and medical / 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).
- Coordinate creation of Global Statistical Strategic Plan (GSSP) to align program design and statistical approaches with product strategy and EGP.
- Coordinate 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).
- Lead global biostatistics team.
- Lead in the achievement of annual department goals.
- Manage and develop staff.
- Ensure Biostatistics team effectively use assigned supplier resources.
- Coordinate development of Amgen Policies, SOPs and other controlled documents.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications :
Doctorate degree and 4 years of relevant experience
Masters degree and 7 years of relevant experience
Bachelors degree and 9 years of relevant experience
Preferred Qualifications :
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, we'll 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 :
Apply now
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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.
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.
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