Location: Waltham,MA, USA
Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company's pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases.
We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation - TRUE Innovation!
Position Summary:
The AD/Director, Biostatistics is responsible for leading the development and execution of statistical aspects for global clinical programs. He/she will provide project leadership and hands-on technical statistical support. This position reports to the Executive Director, Head of Biostatistics.
Key Responsibilities:
* Independently lead the development and execution of all statistical aspects for one or more clinical development programs, including contribution to study trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions, and publications.
* Review or author statistical analysis sections of protocols, statistical analysis plans (SAP), clinical study reports (CSR), regulatory documents or scientific publications.
* Generates or reviews study randomization, sample size/power estimations and key specifications for statistical programming implementation of analyses including programming specifications for analysis datasets and TLFs, including SDTM and ADaM specifications.
* Manage biostatistics and programming vendors.
* Develop statistical programs to ensure quality and accuracy or to perform other pre-specified or ad-hoc analyses as required.
* Work as part of a collaborative, cross-functional team with members from other disciplines.
* Represent Biostatistics, ensuring statistical input is provided throughout the clinical development process.
* Interact with regulatory agencies, and effectively address statistical questions and requests.
* Take accountability for ensuring quality in all planning, design, and execution of assignments associated with the assigned protocol or project.
Requirements / Qualifications:
* PhD or MSc in Biostatistics or related discipline, 8+ years (5+ years for AD) of experience working across all phases of clinical trials in CRO/Biotech/ Pharmaceutical company.
* Solid knowledge of statistical methodology, clinical experimental design and analysis for clinical trials.
* Experience working with CROs and vendors.
* Good knowledge of ICH, FDA, EMA, and NMPA guidelines.
* Prior experience supporting global clinical trials.
* Project leadership experience.
* Submission experience is strongly preferred.
* Exceptional interpersonal skills and problem-solving capabilities.
* Excellent oral and written communication skills and ability to effectively communicate statistical concepts to both technical and non-technical stakeholders.
* Experience working with cross-functional teams, including clinical development, regulatory affairs, medical affairs and commercial.
* Experience working with CDISC data standards.
* Proficiency in SAS programming and other statistical software tools.
* Comfortable working in a demanding, fast-paced, start-up culture with evolving processes. Flexible and able to adapt to new situations as the business demands.
* Demonstrates flexibility to work non-traditional work hours when needed, given international operations across time zones.
#LI-Hybrid
Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $173,600 to $237,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas' competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.
Zenas BioPharma is proud to be an equal opportunity employer. We are committed to fostering an environment where diversity is valued. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.