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Upper Merion Township, Pennsylvania, United States
Hybrid
Position Purpose:
The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution to a clinical development program. The AD provides statistical strategies for the clinical trials and regulatory submissions and is accountable for the statistical deliverables within the program. (There are 2 positions available supporting multiple Therapeutic Areas)
Work Environment:
*** This is a hybrid position with a minimum of 3 days onsite in the designated work location weekly. Relocation assistance is not provided.
Main Responsibilities:
Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area. Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions
Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews.
Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents.
Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations.
Provide for project-wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions.
Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA)
Be responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents.
Manage outsourcing operations or work with internal statistical programmers within the responsible program. Ensure timeliness and quality of deliverables by CRO/FSP.
Support or lead improvement initiatives within the department, organization and/or pharma industry.
Prepare abstracts, posters, oral presentations and written reports to effectively communicate results of clinical programs and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge.
Minimum Qualifications:
PhD with 8 years of experience or MS with 11 years of experience in drug development
Experience providing statistical leadership at compound/indication level
Demonstrated statistical expertise and leadership in facilitating and optimizing the (pre/early/full-) clinical development strategy
Solid experience in applications of advanced statistical methodologies
Leading roles in regulatory submissions
Experience in interactions with major regulatory authorities preferred
Experience with CROs (either managing a CRO, or having worked in a CRO) or managing internal deliveries preferred
Track record of innovation preferred
Competencies:
Familiarity with regulatory guidance and interactions -Broad knowledge of clinical development and processes
Ability to collaboratively work and provide leadership in matrix environment -Strong interpersonal and communication skills (verbal and written in English)
Good working knowledge of SAS and/or R
Expertise in a range of statistical methodologies
Demonstrated use of innovative / creative methodology for analysis of clinical data
Familiarity with relevant regulatory guidance documents
The expected base salary range for this position at the Waltham, MA site is $212,000 - $251,000/yr. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay at the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies, geographic location, and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
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About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
