Associate Director Statistical Programmer (Roivant)

JOB SUMMARY:
The Associate Director Statistical Programming will provide an expert-level hands-on support and technical and/or managerial leadership to programmers and CROs. H/she will also develop, maintain, validate and run SAS computer programs that access, visualize, analyze, and report clinical trial data, in accordance with statistical analysis plans, ICH guidelines, and applicable regulatory requirements. The ability to work independently and strong programming and CDISC experience is preferred.

ACCOUNTABILITIES:

• Provide timely support to the study teams on all programming matters per product strategies.
• Function as lead programmer to produce or validate tables, listings, figures, clinical datasets (SDTM) and analysis datasets (ADaM) per study key milestone timelines.
• Mentors junior programmers / CROs. H/she leads statistical programming initiatives and / or are the functional representative at internal and external meetings for the Manager / Director of Statistical Programming.
• Review statistical analysis plans, mapping specifications and other related documents.Assist in developing programming processes consistent with industry best practices. Create and validate global macros or systems that streamline repetitive operations to increase programming efficiency.
• Strong organizational and time management skills. The ability to handle multiple assignments effectively and deal with ad hoc requests.
• Partners with external CROs to perform any of the above tasks. Manage the quality of the CROs deliverables to ensure the highest data quality.
• Participates in the RFP development, contract negotiations and selection of programming and/or new technologies, as needed. Provides training to fellow staff on GCP and good programming techniques, FDA required CDISC standards (SDTM, ADaM, define.xml) needed for submissions to both internal and external partners as needed.
• Other duties assigned as needed.

BEHAVIORAL REQUIREMENTS:
To achieve our Company’s vision and mission, we are committed to hiring people who “do what is right” not because a policy requires it, but because they value ethics and recognize the critical importance of compliance to the success of the business. At Roivant, each individual is accountable for compliance, not just those who work in Legal and Compliance. By weaving compliance into the fabric of our corporate DNA, we safeguard our most precious assets, from our reputation to the trust of the customers and patients who rely on us. We believe that it is only through a culture of compliance, in which ethics are a fundamental part of how we do business, that we guarantee our success in the long run.

Given our commitment to ethics and compliance, we seek to hire likeminded individuals who are committed to ethically-achieved performance. Behavioral requirements for this position include:

• Being an integrity role model by visibly and consistently speaking and acting the values of our Code of Business Conduct and Ethics;
• Timely completing, and ensuring you understand the content of, all required legal and compliance training courses;
• Acting with respect and in a professional manner in all business relationships (with colleagues within Roivant and with external stakeholders).

CROSS-FUNCTIONAL INTERACTIONS

• Collaboration with Clinical Research team for data quality review and cleaning. Addresses ad-hoc requests from Medical Affairs, Medical Monitoring, Data Management, etc. as required.
• Collaborate with Clinical Operations team to ensure delivery of key milestones on time, with high quality and within budget.
• Collaboration with Data Management to implement the CDASH standards for eCRF setup to ensure alignment with FDA requirements for statistical analysis and CDISC conformance and compliance.
• Collaborates 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; ensure that all data management activities have been carried out per industry and internal standard practices.
• Contributes to departmental process and standards initiatives such as CDASH, CDISC SDTM, ADaM and define.xml creation.
• Collaborates with cross functional teams (Non-Clinical, Pop PK group, Regulatory, etc.) on required CDISC submission deliverables (SEND, SDTM, ADaM, define.xml, reviewer’s guides, etc.)
• Leads the selection and management of CROs (including the strategic outsourcing providers) conducting statistical programming activities.
• Partners with external CROs to setup standard Data Transfer Agreements (DTAs).

REQUIREMENTS:
Education:

• Bachelor’s or Master’s Degree in a science/technical related field.

Experience (e.g. Jobs, supervisory, industry, international, etc…):

• A Bachelor’s plus a minimum of 10 years or Masters plus a minimum of 7 years SAS programming experience in a clinical trial environment (Pharmaceutical, Biotech, CRO). Experience in constructing technical programming specifications and producing validated SAS programs. Strong experience in programming to CDISC standards including SDTM and AdaM.

Specialized knowledge, Licenses, etc.:

• Strong knowledge and experience of mapping and validation of SDTM and ADaM datasets. Knowledge and / or experience with the creation and validation of the define.xml document a plus.
• Knowledge and experience in developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards and according to quality, compliance and timeliness requirements.
• Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise. Familiarity with statistical analysis methods and clinical data management concepts.
• A project leader; completes programming tasks independently at a project level. Follows program-wide standards and suggests/develops additional standards; ability to engage key stakeholders.
• Excellent written and verbal communication skills.
• Good organization and negotiation skills with a demonstrated history of teamwork and collaboration; deals well with change and seamlessly assimilates to new projects and stakeholders.
• Expert with using Pinnicale21 tool for CDISC conformance and compliance.
• Expert with managing CDISC controlled terminology.
• Strong Knowledge of FDA/ICH guidelines, and industry standard practices regarding data management.
• Evidence of strong management skills, as shown through management of multiple projects and proven ability to manage, mentor, and motivate staff
• Ability to effectively mentor senior staff to direct and promote teamwork in a multi-disciplinary team setting

Other skills/attributes:

• Demonstrated alignment with Roivant values and culture

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