Overview:
The Associate Director, Biostatistics and Statistical Programming will drive biostatistical activities, performed primarily by vendors, in support of project timelines and budgets related to drug product development at Xeris. The individual will contribute to study design, protocol development, case report form development, clinical study reports, and exhibits for other reports and presentations.
Responsibilities:
- Conducts basic statistical analysis of study data with minimal supervision according to a statistical analysis plan to generate results and insights used to support study findings.
- Applies moderately advanced statistical methods, which may include simulation models and other statistical programming as needed, with guidance.
- Generates sample size and power calculations and randomizations.
- Oversees the review of statistical documents and operational activities outsourced to CROs ensuring adherence to cost, timeline, and data quality requirements to ensure that the analysis plans use the most appropriate statistical methods and that the data displays such as tables/figures/listings are accurate and complete.
- Programs or independently validates key study results to support interpretation of data.
- Provides statistical programming support to other clinical studies or regulatory submissions where another biostatistician is assigned as the sponsor lead.
- Works closely with Data Management by providing input to data management-related documents and assisting with data review and cleaning activities, as needed.
- Ensures compliance of data packages to regulatory requirements and CDISC and industry standards.
- Assists in the development of abstracts, manuscripts, presentations for scientific congresses.
- Closely collaborates and participates in knowledge sharing with other team members including non-statisticians to assist with interpretation and understanding of results.
Qualifications:
- MS/MPH degree in biostatistics, statistics, or epidemiology
- A minimum of six years of clinical trial experience as a statistician and/or statistical programmer in the pharmaceutical, biotech, or CRO industry
- Experience in Phases I-III of the clinical drug development process
- Knowledge and basic understanding of statistical concepts and techniques commonly applied to the analysis of data from clinical trials and the ability to tackle from basic to moderately complex statistical or data issues
- Basic understanding of real-world data and observational studies.
- SAS programming experience required, R experience is a plus
- Working knowledge of CDISC standards
- Prior use and implementation of sample size and power calculation software (e.g., nQuery and PASS) preferred
- Working knowledge of EDC systems
- Competencies: Attention to Detail, Organizational skills, Adaptability, Multi-Tasking, Strong Written & Verbal Communication skills, Teamwork & Collaboration, Critical Thinking, Problem Solving, Presentation Skills
- Working Conditions: Preference will be given to qualified candidates in the Chicagoland area. If based in Chicago, the position is hybrid and a minimum of three days per week on-site at Xeris’ Chicago office is required. On-site requirement may change at management’s discretion.
- Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
The level of the position will be determined based on the selected candidate’s qualifications and experience.
#LI-REMOTE
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
The anticipated base salary range for this position is $140,000 to $240,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
