Responsible for all aspects of project and trial strategic leadership, design, planning, communication. Supervises internal junior biostatistician, provides project team and functional support, and oversees CRO biometrics groups. Performs trial design, planning, interim and final statistical evaluations and reporting. Presents results and interpretation to internal and external audiences, including regulatory authorities. Supports due diligence and regulatory negotiation, as well as research collaboration projects.
Responsibilities
Position Summary:
This unique position offers an ambitious candidate the opportunity to contribute and learn through direct exposure to a wide spectrum of biometrics activities in support of Clinical Development, Regulatory Agency submissions, and Medical Affairs, including a strong focus on Real World Evidence (RWE). The incumbent will be responsible for planning and executing a range of biostatistical activities to support Medical Affairs publications and studies, as well as clinical development studies. These responsibilities may also include ad hoc analyses of existing databases, study design simulation, meta-analyses, and data mining. Tasks include planning, programming, and executing statistical analyses; contributing to content and review of presentations and manuscripts; and occasional instructing and reviewing third party statistical planning and analysis work.
This role will be onsite in Waltham, MA.
Knowledge/Skills Needed:
- Experience in the development of statistical plans, programming, and analyses of Phase I-IV clinical trials
- In-depth experience of SAS and R
- Strong analytical and problem-solving abilities, with excellent organization skills and the ability to work multiple tasks simultaneously
- Flexible to changing priorities, detail-oriented, works well under pressure and able to take on new challenges
- Ability to work in a collaborative environment, desire to learn and improve skills
- Ability to communicate statistical information to non-scientists, willingness to educate internal teams
- Experience with standard statistical methods including but not limited to parametric and non-parametric analysis, Bayesian statistics, survival analyses, longitudinal data analysis, logistic regression, methods used in handling missing data, MMRM, GEE, multiple testing procedures, multivariate statistics, meta-analysis and categorical data analysis
- Experience in collaboration with Medical Affairs, HEOR, and Epidemiology to support real-world evidence generation aligned with medical strategy and patient needs
- Ability to guide data management and programming in developing standards for building databases, edit checks, and statistical programming for data analyses.
- Experience in managing statistical and programming activities of CROs
- Experience in planning and preparation of integrated summary documents- ISE, ISS
Basic Requirements:
- At least 8 years of experience in pharmaceutical, biotech, and/or CRO setting
- Ph.D. in Biostatistics, Statistics or Applied Mathematics
Preferred Requirements:
- Ability to understand and develop statistical and patient-based models, using the latest tools and methodologies
- Strong analytical skills and demonstrated experience in gathering, interpreting and analyzing data
- Strong statistical experience in clinical research and drug development
- Experience in US and/or Non-US submissions
- Strong communication and interpersonal skills; ability to interact with cross-functional teams
Travel Expectations:
- Overnight travel ~10%
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About Us
Why join Team Alkermes?
Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.
Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
