Director/Sr. Director, Biostatistics
This is a key leadership role at a growing, fast-moving privately held biopharmaceutical company. The candidate will head the company’s biostatistical function and provide strategic/technical leadership across all phases of clinical development.
Specific responsibilities include strategic/technical input to across various phases of clinical development; management of external contract research organizations (CROs)/vendors/consultants and/or internal team members; design and/or development of statistical analysis plans (SAPs), clinical protocols, clinical study reports (CSRs), and key regulatory/clinical documents; development of SAS programs; and design of table, listing, and figure (TLF) shells for data outputs.
- Develop and implement standards and practices to ensure statistical integrity of deliverables.
- Evaluate, select, and manage CROs, vendors, and consultants for statistical deliverables, while ensuring consistency of approach, adherence to timelines, high quality, and reasonable cost.
- Direct the statistical design, conduct, and analysis of clinical trials across all phases.
- Review clinical protocols and case report forms (CRFs) for soundness of trial design.
- Author and/or review statistical analysis plans for all clinical studies
- Perform and/or review the analysis and interpretation of clinical study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
- Ensure that the interpretation of data obtained from clinical trials is accurate, scientifically sound, and credible
- Interact with FDA or ex-US authorities to ensure alignment on all regulatory requirements.
- Provide strategic and operational oversight of statistical programming activities, including the management of external vendors, consultants and/or internal team members.
- Provide guidance and expertise to the development team on all biostatistical-related subject matters.
- Stay abreast of emerging technologies and concepts related to statistical methodology
- MS or PhD in Statistics or Biostatistics with 8+ years of direct experience in biotechnology/pharmaceutical industry.
- Advanced knowledge of statistical analysis methods and data presentation formats
- Experience with the oversight of the statistical programming
- In-depth experience in the design and development of SAPs, study protocols, clinical study reports.
- Hands-on experience with NDA/regulatory filings, preferably as the lead statistician for the filing.
- In-depth working knowledge of clinical operations and data management
- Knowledge of US and ex-US regulations and guidelines.
- Clear and effective interpersonal communication skills and ability to present complex data to project teams and executive management
- Proven ability to build cross-functional relationships
- Strong leadership and problem-solving abilities
- Ability to influence business stakeholders on key decisions
- Knowledge of industry standards, including but not limited to, FDA/ex-US regulatory guidelines, ICH guidelines, and CDISC data structures.
- Proficiency in SAS, MS Word, Excel, PowerPoint, and Project.
About Spruce Biosciences
Spruce is driven by a mission to develop meaningful therapies for patients with rare diseases. Our growing team brings a diverse history of drug development experience, scientific and medical expertise, effective company leadership, and spirited collaboration.
As we expand, we continue to welcome passionate and talented individuals who share our desire to create new possibilities in medicine.
Spruce offers a competitive compensation package and a rewarding work environment. Join an up-and-coming biotech company in San Francisco fostering innovation, collaboration, and ultimately a streamlined approach to drug development.
If you think Spruce may be the right place for you, please submit a cover letter and your resume/CV.
Spruce Biosciences is an Equal Opportunity Employer.
Principals only; no recruiters please.