Manager/Associate Director, Biostatistics (Dermatology - Immuno
|Job Title:||Manager/Associate Director, Biostatistics (Dermatology - Immuno|
|Location:||New Jersey, USA|
|Salary:||US$160000.00 - US$180000.00 per annum + 18% bonus + stock|
|Contact Name:||Cat Cappell|
|Job Published:||August 29, 2018 21:47|
As the Lead you will be a member of cross-functional development teams and will support Biostatistics TA Head to provide expert and independent statistical leadership in support of an asset (Dermatology focused) within the Immunoscience unit, including guidance on statistical methods, appropriate study design, data analytical approaches and interpretation of results for an asset. This unit acts like a biotech within a large pharma so you get to work for a lean, flexible and innovative company while having the stability of a company that is a key player in the market.
Support the Biostatistics TA Head to ensure execution of development strategy with respect to development of asset specific methodology, study designs, data collection, reporting and interpretation as well as regulatory and HTA interactions
Develops an effective partnership with the Biostatistics Asset Leads (BAL) to ensure the team's ability to execute with quality in agreed to timelines. Provide statistical guidance/oversight to BAL at the strategic partner.
Demonstrate a high degree of knowledge regarding the assets and TA including knowledge of the underlying disease(s) and potential mechanism(s) of action, as well as current treatment landscape, up-to-date scientific literature and issues related to regulatory submission history of related products.Â
Collaborate effectively with colleagues from multiple drug development functions by driving statistical thinking, and proper data interpretation.Â
Influence the broader organization with respect to innovation in clinical study design.
Ph.D. (or equivalent) in Statistics or related field.
Ideally 10+ years experience in Pharmaceutical/R&D or other related experience, including supporting regulatory filings in multiple regions (e.g. US, EU, Japan).Â Minimum 7 years experience.
Experience in planning for & participating in regulatory meetings, (e.g. US FDA).Â
Significant experience engaging with CRO's and managing statisticians
Expertise in general & cutting edge statistical/clinical trials methodology & ability to apply to relevant clinical development framework.Â Demonstrated ability in solving complex statistical problems.
Excellent verbal and written communications skills. Ability to work successfully in cross-functional teams leading to successful global regulatory filings and approvals. Strong communication/presentation skills with ability to tailor the message to the key stakeholder for effective impact and influence.
Ideally have led a drug to submission
Needs to have previous experience working on clinical trials focused in Dermatology
Needs to have an understanding of immunotherepy / immunoscience
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