Description
Director, Biostatistics Consulting (DBC)
Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.
Why Syneos Health
- #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves.
- Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
- We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
Job responsibilities
- Provide strategic biostatistical inputs to high priority sales opportunities to help increase revenue with emphasis on methods to cut costs, decrease time, and increase probability of success for drugs under development by Syneos Health clients.
- Provide guidance on complex innovative designs (CID), including but not limited to master protocol, Bayesian adaptive design, adaptive design, and synthetic control arm.
- Represent clients at meetings with regulatory authorities to justify study design or analysis and to clarify or challenge regulatory requirements. Write questions to pose to regulatory authorities, interpret correspondence and recommendations from regulatory authorities.
- Provide strategic biostatistical inputs at the study level for emerging and established pharma companies with whom Syneos Health has entered a partnership, with key focus on large programs, for which strategic biostatistical input aims to help win further high value business or help retain existing business.
- Maintains a good working knowledge of clinical drug development, ICH, and other regulatory guidelines, and biostatistics methodologies in order to effectively serve as a Biostatistics Department consultant.
- Develops and provides training for Biostatistics associates.
- Promotes innovative design and fit-for-purpose analysis approaches that address appropriate clinical questions in protocol design.
- Provide guidance for design options, and simulation specifications to the statistical programmers, interpret and communicate modeling and simulation results to inform and guide the determination of the optimal clinical trial design.
- Develop strong partnership with broader Biostatistics leadership team, project teams, and other cross functional departments/therapeutic business units (TBUs).
Qualifications What we're looking for
- Extensive experience of strategic statistical leadership at product level of one complex program or multiple programs of moderate complexity.
- Excellent computing, modelling and simulation skills using R, SAS, OpenBugs, RShiny (preferrable), etc.
- Scientific research/publications in one or more areas of statistical science. External visibility in biostatistics profession (e.g., through industry committees/forums/consortium, links to academia).
- Strong knowledge of drug development and Health Authority guidelines. Strong understanding of multiple therapeutic areas.
- Drive for innovation and quick adaptation to new industry trends.
- Well recognized statistical and strategic leadership among statisticians and cross-functional teams, strong technical and effective communication skills.
- Demonstrated strong skills in building partnerships and collaborations. Demonstrated skills in coaching and mentoring associates, and in presenting statistical concepts to non-statisticians.
- Expectation for travel under 10%.
- Highly proficient skills reading/writing (unless hired specifically for non-English skills to interact with clients and regulatory agencies, e.g., Chinese or Japanese).
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and...
#J-18808-Ljbffr
