Associate Director, Biostatistics (HEOR)
Are you looking to join a biotech that has its eye on meteoric growth? How about a company that is focused on employee growth and development? What about gaining experience working with Rare Disease? If you answered yes to any of these questions, then this opportunity just might be for you!
I am partnering with a Biotech in San Diego looking to grow their biometrics team with the addition of a Associate Director, Biostatistics who will report to the VP of Biometrics. In the role of AD, Biostatistics, you will be providing statistical support to Health Economics and Outcomes Research, Market Access, and Real World Evidence activities in support of drug development and commercialization. You will oversee statistical aspects of assigned studies or projects to ensure that scientific, regulatory, and quality requirements are met and that plans are aligned with development and commercialization goals.
- Responsible for all statistical aspects in supporting the assigned compound's development from general development plan to individual study design and implementation.
- Initiate, drive and implement novel methods and innovative trial designs in alignment with the Project team.
- Lead statistical aspects of submission activities and responsible for delivering scientifically and statistically sound regulatory documents; meetings with and responses to health authorities and provide statistical support to other drug development and commercialization activities, as needed.
- Contribute to interactions with external review boards/ethics committees, external consultants and other external parties with oversight as appropriate.
- Represent the Biometrics department on cross-functional teams for the assigned compounds. Responsible for seeking and achieving functional alignment and ensuring line function awareness of major activities throughout the phases of assigned compound's development.
- Collaborate with other line functions effectively and contribute as an integrated member in driving informative decision making.
- Explain statistical concepts and interpret study findings in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements.
- Establish and maintain sound working relationships and effective communication within the Project Team and Biometrics organization.
- Oversee statistical vendor's deliverables and accountable for timeliness and adequate quality of all biostatistics deliverables for the assigned compound(s).
- Contribute to thoughts and actions towards building efficient analysis and reporting processes.
- Other duties as assigned.
Skills and Requirements:
- PhD (in Statistics/Biostatistics or equivalent) with 7+ years relevant work experience or MS (in Statistics/Biostatistics or equivalent) with 10 + years relevant work experience.
- Oncology clinical trial experience is a plus.
- Solid experience in drug development across phases and good knowledge about health authority guidelines.
- Regulatory submission experience is a plus.
- Proven knowledge and expertise in statistics and its application to clinical trials; able to explain statistical designs and concepts to different audience; demonstrated capacity of continued learning and application of novel statistical methodology.
- Proficiency in use of statistical software packages (e.g. SAS, R).
- Demonstrated effectiveness working on cross-functional teams to achieve team objectives.
- Excellent project management and matrix leadership skills.
- Strong communication skills with the ability to create effective collaborations within Biometrics as well as with non-statistical functions.
What they bring to the table:
- Competitive Compensation (Paid time off, Paid holidays, bonus program, equity award, 401k match)
- Competitive benefits package
- A culture and work environment that recognizes employees as their most valuable asset
- Career development and training
- Relocation (If necessary) to sunny San Diego
If all of this sounds like something you would be interested in, please apply through the link below or please contact Hunter Lux at (+1) 213-294-2997 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.