Associate Director, Biostatistics and Statistical Programming

Associate Director, Biostatistics And Statistical Programming

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

The level of the position will be determined based on the selected candidate's qualifications and experience.

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.