Job Description

What you should know about Anaptys:

Anaptys is an immunology-focused, clinical-stage biotechnology company with a 19-year track-record of discovering life-changing therapeutic antibodies. Over that time, we have worked to create a work environment where every role has meaning, every team member is respected and every day is a chance to make a difference for people living with autoimmune and inflammatory diseases.

Our portfolio today includes our PD-1 agonist, in a Phase 2b trial for the treatment of rheumatoid arthritis and in a Phase 2 trial for the treatment of ulcerative colitis. We also have other immune cell modulator candidates in our portfolio, including ANB033, an anti-CD122 antagonist antibody, entering a Phase 1 trial and ANB101, a BDCA2 modulator antibody, in preclinical development.

Our success is rooted in the diversity of our teams’ experience, knowledge and background. We’re doers, thinkers and collaborators who embrace and live by our values: accountability, transparency and humility.

Here’s What You Will Do:

The Director of Biostatistics is a member of a cross-functional clinical development team and contributes to clinical trial design, study protocol development, statistical analysis planning, interpretation of results, preparation of regulatory submissions and publications. This position will serve as statistical lead and work collaboratively with data management, statistical programming, external partners, medical director(s), clinical scientists, clinical study managers, project managers, PK scientists, and other members of the study team.

Essential Functions

• Leads the development and execution of all statistical aspects for clinical trials, including contribution to clinical trial design, statistical analysis planning, study results presentation and interpretation, clinical study report, regulatory documents (IND submissions, briefing package, DSURs, etc.), regulatory submissions, and publications.
• Represents Biostatistics function in project and study team meetings with cross functional team members and serves as lead statistician on multiple studies/projects across different therapeutic areas.
• Accountable for ensuring quality in planning, design and execution of assignments associated with the assigned projects.
• Contributes to clinical study designs and strategic discussions around the clinical development plan.
• Performs statistical simulation and / or power calculations to determine the appropriate sample size for a clinical trial.
• Authors statistical and sample size sections in developing clinical study protocols.
• Collaborates with Data Management and other members of the study team on the design or modification of the eCRFs.
• Ensure the quality and accuracy of study data and statistical outputs.
• Perform quality control checks on key efficacy and safety endpoints to validate data.
• Provides vendor management and oversight and ensure quality in CRO deliverables such as statistical analysis plan and TFLs.
• Participates in meetings with regulatory authorities (FDA, EMA, etc.) as necessary.
• Contributes to scientific presentations and manuscripts for publications, summarizing data collected in clinical trials, or analyzing external data.
• Involved in standard operating process development for department.
• Utilizes project management principles both upstream and downstream to ensure study deliverables are accomplished according to the plan.

Requirements

Here’s What You Will Bring to Anaptys:

Education & Experience

• Ph.D. in statistics, biostatistics, mathematics, or related quantitative field with 10 or more years of experience in biopharmaceutical /CROs; or MS in statistics with 12 or more years of experience in biopharmaceutical/ CROs.
• Understanding of ICH GCP and good knowledge of industry practices and standards as related to biostatistics and clinical trials.
• Extensive knowledge of statistical methodology and data analytic methods used in clinical trials.
• Knowledge or experience in adaptive designs or innovative statistical methodology in the clinical, and regulatory environments.
• Statistical computing and simulation skills with proficiency in one or more programming languages such SAS and R.
• Experience in Bayesian methodologies and multiple imputations
• Proven track record of planning, creating, and delivering Integrated Summaries of Safety and Effectiveness (ISS and ISE) and related reports for regulatory submissions.
• Experience with CDISC standards, including SDTM, ADaM, and CDASH standards.
• Excellent verbal and written communications skills, including the ability to clearly articulate statistical concepts to non-statisticians.
• Ability to engage effectively as a team player within a fast-paced working environment.
• Ability to be flexible and adapt quickly to the changing needs of the organization

What’s Included in Your Compensation and Benefits Package:

Our generous benefits package is industry leading. Beyond base salary and a target bonus, we offer stock options, RSUs and a 10% 401k match to help you secure your financial future. Our robust time off policy provides employees a unique holiday schedule that incorporates long weekends throughout the year, in addition to the yearend company closing and additional vacation time.

Of course we round out our benefits with company sponsored dental, vision and life insurance plans. Our medical plans are benchmarked and are considered extremely competitive.

The salary range for this position is $160,000 - $207,000 with a 20% bonus target. Anaptys considers a variety of factors when determining base compensation, including experience and qualifications. These considerations mean actual compensation will vary

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.

Work Environment

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate.

May be required to travel by plane or car

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Job Tags

Similar Jobs