Associate Director, Statistical Programming

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Job description

Job Type Full-time

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 two checkpoint agonists: ANB032, our BTLA agonist, in a Phase 2b trial for the treatment of atopic dermatitis and rosnilimab, 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 Associate Director, Statistical Programming is responsible for successful execution of study-level, compound level deliverables and milestones over the drug development life cycle in addition to leading various initiatives for department improvements. They will ensure consistent programming standards across their compound(s), bringing creative solutions to improving and implementing various data flows to and from the Statistical Programming function including CDISC standards. This position is responsible for interacting with Statisticians, Clinical Data Managers, Clinical Trial Managers, and other cross-functional stakeholders to provide programming support for clinical studies and ad hoc analyses.

Working with and leading compound-level teams as well as successfully collaborating with key Biometric stakeholders and senior management teams. They will bring excellent business acumen, presentation, communication, and negotiation skills along with the ability to drive meaningful change across all levels.

Essential Functions You Will Be Responsible For:

• Provide statistical programming support to generate SDTM and ADaM data sets, tables, listings, and figures for individual studies as well as ISS/ISE analyses
• Provide programming support to clinical data management including identifying, reporting, and resolving raw data issues
• Participate in the review of statistical analysis plans, table specification, develop specification for SDTM and ADaM data sets.
• Conduct CDISC Standardization activities for clinical research projects from study start-up through submission to regulatory agencies
• Responsible for SDTM compliance and validation using software accepted by the FDA
• Review, and comment on CRFs, annotated CRFs, and edit checks and related documents.
• Participate in study team meetings and address issues that may affect statistical programming.
• Support and participate in the preparation of clinical study reports, ISS/ISE development, regulatory electronic submissions, and annual DSUR and safety reports.
• Perform ad hoc analyses and data validation.
• Cooperate with CRO statistical programmers and validate their work.
• Develop and contribute to Biometrics SOPs and working documents related to EDC studies, FDA requests, independent validation, and general statistical programming processes.

Requirements

Here's What You Will Bring to Anaptys:

Education & Experience:

• BS in biostatistics, computer science, or related fields, Master's degree preferred
• 10+ years of biopharmaceutical experience and 5 years of leading programming activities in the biotech or pharmaceutical industry.
• The ideal candidate must be able to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time.
• Proficient of SAS programming in a regulated clinical research environment
• Experience of leading late-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, figures, and listings.
• Experience in BLA, NDA/sNDA and EMA submissions.

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.

Base Salary: $151k - $194k.

Anaptys considers a variety of factors when determining base compensation, including experience and qualifications. These considerations mean actual compensation will vary.

What Else You Should Know:

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.

This position requires working with biological and/or chemical hazards.

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.

Salary Description $151,000-194,000,17.5% bonus target,10% 401k Match

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