Director/Senior Director, Biostatistics/Biometrics
Location: New York, New York, United States
OUR COMPANY
Volastra Therapeutics, Inc. is a clinical stage oncology biotechnology company based in New York City. Founded by Lewis Cantley, Samuel Bakhoum and Olivier Elemento, Volastra is focused on developing therapeutics that exploit chromosomal instability (CIN) as a unique vulnerability in cancer. The company has grown since its founding in 2019 and now supports ongoing discovery efforts as well as a growing clinical organization.
Volastra's most advanced pipeline medicines are two distinct inhibitors of KIF18A, a novel therapeutic target. The first medicine, VLS-1488 was internally discovered and is currently in Phase I for the treatment of advanced cancers. The second KIF18A inhibitor is sovilnesib, a clinical stage KIF18A inhibitor licensed from Amgen in February 2023 and for which the company is in the process of initiating in Q2 2024.
Volastra is financed by top US and European venture firms, including Arch Ventures, Polaris, Vida, Droia, Catalio as well as from strategic investor Eli Lilly. In addition to venture funding, Volastra has a multi-year drug discovery collaboration with Bristol Myers Squibb and a biomarker discovery partnership with Microsoft to use artificial intelligence to measure chromosomal instability. The company has a highly experienced senior leadership team and a world class advisory board.
The company operates out of office and laboratory space in West Harlem, New York City, within easy traveling distance of most areas of the city, Westchester County, and New Jersey. Please visit www.volastratx.com for more information.
JOB DESCRIPTION
The role of Director/Senior Director, Biostatistics will report to the VP of Clinical Development and work closely with the entire development organization to support the successful development of our clinical stage assets. The Director/Senior Director, Biostatistics will be responsible for the design, implementation, and delivery of Volastra’s clinic trial biostatistical analyses.
The ideal candidate works collaboratively, is detail-oriented and self-motivated, and has a strong background in Biostatistics, Biometrics, or a related field, with extensive experience in oncology clinical trials and drug development.
Volastra is a fast-paced biotech company of passionate employees, and there is ample opportunity for the ideal candidate to grow and develop within the organization.
RESPONSIBILITIES
- Lead the Biostatistics function to ensure timely and high-quality implementation and delivery of statistical analysis methods, and programming outputs for clinical trials including interim analyses, final analysis, IB, DSUR, CSR and publications.
- Inform clinical development by providing input into study design, sample size calculation, and statistical methodology to design optimal clinical trial programs.
- Collaborate with the cross-functional clinical team, including Clinical Development, Clinical Operations, Biomarkers and Translational Sciences to ensure seamless communication and coordination of Biostatistics deliverables.
- Develop and maintain strong relationships with external vendors, such as CROs and statistical or data management consultants to build effective communication and collaboration with these partners to ensure the success of clinical trial programs.
- Provide input and support for regulatory submissions and interactions.
- Serve as the primary point of contact and "single source of truth" for clinical trial data analysis, ensuring consistency and accuracy of data outputs across all internal and external forums.
- Develop and implement statistical analysis plans and subsequent analyses.
- Draft SDTM/ADaM specifications and program datasets/tables/listings/figures.
- Foster a collaborative and supportive team culture and provide hands-on guidance and knowledge-sharing to support the efficiency and effectiveness of the team.
- Identify and address challenges or roadblocks in biostatistics deliverables proactively and work closely with other team members and stakeholders to develop solutions and ensure timely resolution.
- Ensure compliance with regulatory requirements and guidelines for clinical trial data analysis and reporting.
- Develop SOPs and processes for the Biostatistics function.
QUALIFICATIONS
- PhD or Master's degree in Biostatistics, Statistics, or a related field.
- At least 7 years of experience in the biopharmaceutical industry, with a strong track record in oncology development.
- Extensive knowledge of clinical trial design across all stages of drug development, various statistical analysis methods (including Bayesian methods, hierarchical models, and sequential analyses), and regulatory requirements for drug development, especially as it relates to the unique aspects of oncology development.
- Excellent communication and interpersonal skills with the ability to work effectively in a matrix environment and with CROs.
- Experience with SAS, R and other statistical software commonly used in the industry.
- Experience authoring the statistical sections of trial documents, including Statistical Analysis Plans (SAPs).
- Understanding of the landscape and shifts in approaches to clinical trial design and statistical analysis methods for drug development.
- Familiarity with CRF design and Medidata Rave outputs a plus.
Volastra is a team of dedicated individuals working to advance therapies for patients with cancer. As such, individuals will from time to time have the opportunity to work on projects and take on responsibilities that may fall outside their scope of work. Job is based in NYC with a flexible option for hybrid work.
SALARY RANGE
Approximately $175,000- $245,000 which may vary depending on qualifications, experience, and ultimate leveling