Associate Director, Statistical Programming

Title:

Associate Director, Statistical Programming

Company:

Ipsen Bioscience, Inc.

Job Description:

Summary / purpose of the position

The Associate Director, Statistical Programming will be working in a cross‑functional team, responsible for providing study level statistical expertise and leadership in the development of Ipsen’s assets. 

This position reports to the Head of Statistical Programming, based in the USA.

Main responsibilities / job expectations

Position will participate in exploratory and production programming, programming infrastructure building including macro creation and set up programming processes, project coordination, CRO management and QC of vendor programming across therapeutic areas such as Oncology and Rare Disease, to ensure the efficiency and quality of Biostatistical/Programming deliverables; ensure that all clinical datasets meet the standards required for regulatory submissions for all INDs and NDAs/MAAs; responsible for Statistical Programming activities, including analyzing, integrating and reporting of clinical trial data in order to produce quality and timely deliverables; perform data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data; provide statistical programming support to generate derived analysis data sets, tables, listings, and figures for Clinical Study Reports, regulatory submissions, annual IND safety update reports and Integrated summaries (ISS/ISE); create/QC of CDISC SDTM and ADaM files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources; complete full QC validation of in-house created graphs/tables/figures; interact with Statisticians, Programmers and other members of the clinical team, perform ad hoc analysis and generate outputs according to the requirements; review and comment on CRFs, annotated CRFs, Data Management Plan, Data validation plan, edit check specifications and study related documents; participate in operations meetings and address issues that may influence statistical programming and data management; work with CRO statisticians, statistical programmers and review/QC their work/deliveries; understand clinical trial design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation; and, execute and manage multiple simultaneous projects and deadlines with shifting priorities and resources in a fast-paced working environment.

Knowledge, abilities & experience

Bachelor’s degree (or foreign equivalent) in Biotechnology, Statistics, Mathematics, other Scientific Disciplines, or a related field plus eight or more years of experience in the job offered or in a related occupation. Experience must include the following:

• Demonstrable knowledge of SAS programming language.

• Demonstrable knowledge of regulatory requirements (FDA, ICH).

• Demonstrable experience in organizing NDA/s NDA regulatory submissions.

• Demonstrable experience of extracting, manipulating, summarizing, analyzing, and presenting data using SAS procedures.

• Demonstrable experience of SAS/MACRO, SQL, and SAS/BASE procedures.

• Demonstrable experience of SAS/GRAPH and Statistical procedures.

• Demonstrable experience of Clinical data and medical dictionaries.

• Demonstrable understanding of clinical trials - how programming deliverables fit in to the process, what types of data are collected.

• Demonstrable data structure understanding (tall and wide structures), including concept of patient.

• Demonstrable experience in developing and QC of SDTM, ADaM, Define XML and Reviewer’s Guide as per the CDISC specifications.

• Demonstrable ability to draft programming requirements from SAP.

• Demonstrable experience with study reporting; and,

• Demonstrable ability proposing and implementing solutions to technical coding issues

• Demonstrable ability to lead programming team and manage deliveries with quality and timeliness

Key Technical Competencies Required

• Strong attention to detail, excellent and direct communication skills, strong interpersonal skills, and cross-cultural understanding and sensitivity
• Ability to see the big picture, while keeping an eye on the detail.
• Ability to take initiative with a positive attitude in all circumstances.
• Flexible; independent problem solving and self-direction.
• Eager and interested in learning and growing
• Thorough knowledge of statistics and the drug development process
• Understanding of SAS programming concepts and techniques in the pharmaceutical industry and ability to correct limitations in strategy proactively
• Ability to manage multiple complex projects and assess resource needs
• Travel required up to 15% of time

Communication & Interpersonal Skills

• Language: English is required
• Written:  excellent
• Verbal:  excellent
• Interpersonal: excellent
• Excellent verbal and written communication within the group and across other functional areas

In order to maintain a safe work environment, Ipsen requires all employees to be fully vaccinated against the Covid 19 virus at the time of employment.

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.