Associate Director, Biostats
Location
New Jersey
Posted
65 days ago
Salary
$146.6K - $220.0K / year
Postgraduate Degree8 yrs expEnglish
Job Description
• Act as lead and main point of contact related to Statistics for designated compound/indication
• Follow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve efficiencies
• Engage with regulatory authorities on compound/indication level discussions
• Ensure consistency of statistical methods and data handling across trials
• Ensure all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor
• Provide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniques
• Represent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or Partner meetings, as applicable
• Ensure availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs
• Support development and communication in relation to communication strategy and/or scientific input to presentations, posters, and articles
• Engage with regulatory authorities on trial level discussions
• Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable
Job Requirements
- Master's or PhD in a statistical discipline
- 8+ years of experience in relevant area preferred, or demonstrated capability
- Experience in statistical analysis, modelling and simulation and adaptive trial designs
- Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred
- Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics
- Experience with the relevant regulatory requirements for biostatistics processes and SOPs
- Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies
- Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions
- Experience directing multiple complex projects/studies in a technical capacity
- Proven performance in earlier role/comparable role
Benefits
- 401(k) Plan: 100% match on the first 6% of contributions
- Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
- Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
- Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
- Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
- Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses
Related Guides
Related Categories
Related Job Pages
More Director Jobs
Global Microsoft Alliance Director – VP
Hitachi Solutions AmericaA global cloud-services, systems integrator with leading capabilities across all Microsoft applications and technologies
Director65 days ago
Full TimeRemoteTeam 501-1,000H1B Sponsor
Global Microsoft Alliance Director driving business development and partnership with Microsoft
AzureCloud
Product Monetization Director
HackerOnePeace of mind from security's greatest minds. #TogetherWeHitHarder
Director65 days ago
Full TimeRemoteTeam 201-500Since 2012H1B Sponsor
HackerOne seeks a Product Monetization Director to define and embed monetization strategies.
Director of Start-Ups, Integration
NorthStar AnesthesiaTaking Great Care of Our People, So They Can Take Great Care of Our Patients.
Director65 days ago
Full TimeRemoteTeam 1,001-5,000Since 2004H1B Sponsor
Director of Start-Ups and Integration overseeing anesthesia contract start-up and integration
PMP
Texas
Director65 days ago
Full TimeRemoteTeam 10,001+Since 1910H1B No Sponsor
Oversee corporate accounts functions at Medline's environmental services division