Associate Director, Biostats
Genmab
full-time
Posted on:
Location Type: Remote
Location: New Jersey • United States
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Salary
💰 $146,640 - $219,960 per year
Job Level
About the role
- 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
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
statistical analysismodellingsimulationadaptive trial designsbiostatisticsdata handlingintegrated analysistrial designstatistical methodologiesregulatory submissions
Soft skills
leadershipcommunicationcollaborationscientific advicecoordinationnetworkingpresentation skillsorganizational skillsproblem-solvingstrategic thinking
Certifications
Master's degree in statisticsPhD in statistics