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 Senior Manager, Statistical Programming, will independently lead and execute programming activities aligned with project strategies, supporting clinical studies, study reports, and regulatory submissions. This position reports to the Sr. Director, Statistical Programming.
Responsibilities:
- Act as the primary statistical programming contact and knowledge expert for the assigned protocols/studies.
- Provide oversight of statistical programming activities, including activities of CRO programming team(s). Ensure deliverables are met with quality and according to study timelines and are within scope of work.
- Collaborate across functions (e.g., Biostatistics, Data Management, Clinical Operations, and other functions) to provide programming support.
- Review SDTM and ADaM specifications, datasets, define.xml, reviewers guide documents and validation reports.
- Perform QC of SDTM datasets, ADaM datasets and TFLs.
- Program TFLs for ad hoc analyses, posters, and presentations.
- Participate in review of clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings shells.
- Mentor and guide junior programmers.
Qualifications:
- Master’s degree in Biostatistics, Computer Science or related discipline, 5+ years’ experience working across all phases of clinical trials in CRO/Biotech/ Pharmaceutical company; or Bachelor’s degree with 7+ years of relevant experience.
- Experience managing CROs and vendors.
- NDA/BLA and other regulatory filing experience.
- Experience with ISS/ISE.
- Strong knowledge of CDISC standards for SDTM and ADaM.
- Strong knowledge of ICH, FDA, EMA, and NMPA regulations and guidelines.
- Exceptional interpersonal skills and problem-solving capabilities.
- Excellent oral and written communication skills.
- Experience working with cross-functional teams.
- Excellent SAS programming skills.
- Experience with other statistical software tools (e.g., R) preferred.
- 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 $156,000 to $195,000. 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.
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What We Do
Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and delivery of immune-based therapies for patients around the world. Zenas is rapidly advancing a deep portfolio of innovative therapeutics that 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 facing autoimmune and rare diseases. For more information about Zenas BioPharma, please visit www.zenasbio.com
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