Associate Director, Statistical Programming

Job Description

The Position

Responsibilities

• Support and manage statistical programming activities to all clinical development programs and internal initiatives.

• Act as a lead statistical programmer and project manager for the studies, compound and or one or more therapeutic areas (TAs) and interact with other stake holders in the team.

• Provide expert-level hands-on support for all internal statistical programming needs including, but not limited to, ISS and ISE summaries and exploratory data analyses.

• Provide oversight and quality control (QC) of external vendors to ensure the high-quality deliverables and managing timelines for the outsourced studies. Standardize and work on processes improvement and programming within TA and compound and strategize for the long-term seamless management of the program.

• Collaborate with biostatistics, data management and others to provide technical support for ongoing trials, FDA submissions, publications, and other business needs.

• Develop and validate standard department/generic macros and template programs.

• Utilize strong knowledge on CDISC SDTM/ADaM data standards and regulatory requirements.

• Write or review and approve data specifications for SDTM and ADaM.

• Write SAS programs to generate or validate SDTM, ADaM, and TLFs.

• Manage and willingness to coach and mentor junior programmers.

• Participate in the development and implementation of innovative strategies.

• Participate in development, maintenance and adherence to departmental SOPs and Guideline.

• Lead in continuous improvement initiatives within Biometrics and represent in cross functional departmental initiatives.

Required Education, Experience and Skills

• Must have a Master’s degree in Statistics, Mathematics, Engineering, Computer Science, or Life Science plus at least nine years of statistical programming experience in a Contract Research Organization (CRO), biotech or pharmaceutical industry OR a Bachelor’s degree in Statistics, Mathematics, Engineering, Computer Science, or Life Science plus at least ten years of statistical programming experience in a Contract Research Organization (CRO), biotech or pharmaceutical industry.

• Experience working for in regulatory and publication support request and working with an outsourced model also required.

• Advanced working knowledge of CDISC SDTM, ADaM, Define.xml and submission standards; and advanced knowledge of SAS and Macros programming required.

• Must possess strong project management skills to prioritize the tasks and negotiate the timelines and ensure the timely deliverables with highest quality; and excellent written and oral communication skills.

• Ability to manage and work on multiple projects and shifting priorities; and to write generic SAS macros and provide out of the box solutions required.

Telecommuting permitted. 40 hours per week. Must have proof of legal authority to work in the United States. To apply, create a profile and submit your CV for Job Req. #R533377.

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.  Our Vision is clear: A better and healthier every day for every woman.

US and PR Residents Only

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