Overview 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.
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; ensure 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.
Qualifications Education: PhD or MS in Biostatistics, Statistics or related field
Experience: 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
Expertise in CDISC, statistical programming, and/or data standards
About CSL Vifor CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The 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 https://www.csl.com/benefits.
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 CSL’s inclusion and belonging page.
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 the accessibility statement.
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