Associate Director, Statistical Programming                         

Full time position

Company Summary


Axovant develops transformative gene therapies for patients with life-altering neurologic conditions.

 

Our mission is to identify, develop, and bring to market high-impact therapies that have the potential to improve the lives of patients with neurological disorders. Our team is made up of leading scientific experts who are passionate about treating neurological conditions and easing the burden of these life-changing disorders for both patients and caregivers. Our team is motivated by the promise of novel drug development and is driven to find more efficient and effective ways to conduct scientific and clinical evaluations that rapidly deliver impactful medicines to patients in need.

 

Our leadership team has a track record bringing innovative new neurotherapeutic treatments to a global market, and along with our seasoned board of directors, is fully committed to the responsible pursuit of transformative therapies for some of the world's most difficult conditions.

Axovant Gene Therapies seeks an Associate Director of Statistical Programming to join our team. 

 

Primary Responsibilities 

  • Draw on experience with Clinical/Statistical programming with SAS (Statistical Analysis Software);

  • SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) datasets; clinical trials;

  • Drug Development;

  • CDASH (Clinical Data Acquisition Standards Harmonization) standards for eCRF; FDA, CDISC (Clinical Data Interchange Standards Consortium) and regulatory submissions;

  • Statistical Analysis Plan (SAP), SDTM, ADaM mapping specifications skills for clinical trials and statistical analysis to provide timely support to the study teams on all programming matters per Study Protocol.

  • Review statistical analysis plans, mapping specifications and other related documents. Lead statistical programming initiatives and serve as the functional representative at internal and external meetings for the Manager and Director of Statistical Programming.

  • Function as lead developer to produce or validate tables, listings, figures, clinical datasets like SDTM and ADaM  per study key milestone timelines. Develop programming processes consistent with industry best practices.

  • Create and validate global macros or systems that streamline repetitive operations to increase programming efficiency. Mentor junior programmers and Contract Research Organizations (CROs).

  • Partner with external CROs to perform any of the above tasks and manage the quality of the CROs deliverables to ensure the highest data quality.

  • Provide training to fellow staff on GCP (Good Clinical Practices) and good programming techniques, FDA/Health Authorities required CDISC standards (SDTM, ADaM, define.xml) needed for submissions to both internal and external partners. Collaborate with Clinical Operations team to ensure delivery of key milestones on time, with high quality and within budget.

  • Collaborate with Data Management to implement the CDASH standards for eCRF (electronic Case Report Form) setup to ensure alignment with FDA/Health Authorities requirements for statistical analysis and CDISC conformance and compliance.

  • Collaborate with lead project Biostatisticians in the creation, implementation, and maintenance of programming development plans for each project accounting for timelines, resources, and quality deliverables for all project work assigned.

  • Contribute to departmental process and standards initiatives such as CDASH, CDISC SDTM, ADaM and define.xml creation.

  • Collaborate with cross functional teams (Non-Clinical, Pop Pharmaco Kinetics group, Regulatory, etc.) on required CDISC submission deliverables (SEND, SDTM, ADaM, define.xml and TLFs (tables, listings and figures, reviewer’s guides, etc.)

  • Lead the selection and management of CROs (including the strategic outsourcing providers) conducting statistical programming activities.

  • Partner with external CROs to setup standard Data Transfer Agreements (DTAs).

 

Requirements 

Bachelor’s degree (or foreign equivalent) in Computer Science, Engineering or a related field plus 10 years of post-baccalaureate experience reflecting demonstrable ability in the skill set described above.

This is an exciting time to join the field of gene therapy in general, and to become a part of Axovant Gene Therapies’ fast growing dedicated team in particular. Axovant Gene Therapies is a publicly traded company (NASDAQ: AXGT). We offer an exciting, meaningful and collaborative fast-paced environment with a foundation of sound and rigorous science. Competitive compensation and benefits package can be expected.

All interested applicants should send a cover letter and resume to:  HR@axovant.com

Agencies/Recruiters

 

We maintain a list of approved professional recruiting agencies with which we have signed agreements. Candidates will be considered only when the agency has a signed agreement and Human Resources authorization to present candidates for a specified position(s). Candidates submitted outside of this process are considered unsolicited and will not be considered. Agencies interested in establishing a relationship with Axovant may send company information to careers@axovant.com. A member of the Human Resources team will contact you if we require the services your company offers.

AXOVANT GENE THERAPIES

Eleven Times Square, 33rd Floor
New York, NY 10036
United States

+1-833-AXOVANT (1-833-296-8268)

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AXOVANT SCIENCES GMBH

Viaduktstrasse 8
4051 Basel
Switzerland