Senior Director, Statistical Programming

Alkermes•Waltham, MA

1d•Hybrid

About The Position

In this leadership position, the Senior Director, Statistical Programming will serve as the head of statistical programming who oversees all statistical programming activities to support Alkermes’ growing portfolio. This leader will provide guidance on statistical programming technical skills, selecting appropriate and innovative approaches to produce high quality deliverables for in-house and outsourced projects. This role will manage hiring, resource planning and setting strategic vision for the statistical programming group as well as assist on complex deliverables. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work

Requirements

Advanced degree (MS or above) in statistics, computer science or related fields with strong analytical skills
15+ years of experience in pharma/biotech and/or CRO setting
Demonstrated people management and resource planning experience

Nice To Haves

Proven expert in SAS programming and analytical skills using BASE SAS, SAS/STAT, SAS/GRAPH and SAS MACROS etc.
Extensive CDISC SDTM and ADaM knowledge with significant experience writing ADaM specifications using robust and detailed instructions. Strong hands-on SAS programing skills for clinical trial reporting. Experience with electronic FDA submission.
Proficiency in other data analysis programming languages, such as R and Python prefered. Ability to learn new programming language quickly and be motivated to utilize them in the clinical development field.
Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
Strong interpersonal, organizational, and multi-tasking skills
Excellent attention to detail and problem-solving skills
Good project management skills, CRO oversight skills, professional attitude, self-improvement mentality with positive attitude
Effective communicator, both written and oral, who can explain complex technical concepts to non‑technical stakeholders
Ability to think creatively and independently, and to form sound opinions and make sensible decisions in a dynamic environment
Neuroscience experience is a plus
SAS LSAF experience is a plus
Flexible to changing priorities, detail-oriented, works well under pressure
Demonstrate vision for leading the statistical programming group and track record of executing the vision

Responsibilities

Develop and lead a team of high performing statistical programmers to meet corporate regulatory, scientific, and business objectives. Deliveries of the statistical programming group includes ADaM specifications and datasets, TLFs and data submission documents.
Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives.
Establish and maintain efficient statistical programming processes and high quality standards
Ensure CDISC standards, regulatory expectations, and quality requirements are met across all deliverables.
Ability to guide and contribute to complex programming efforts.
Effectively coordinate statistical programming activities with outside organizations, CROs and consultants
Participate in establishment and development of department SOPs
Oversee vendors with respect to key performance indicators, metrics, and program level deliverables and timelines
Maintain an active role in planning and preparation of regulatory submissions
Contribute to project budget/resource planning, re-forecasting, and program milestones, along with CPMs and Clinical Operations management
Work with IT to develop and maintain programming environment to ensure data security and efficient analysis and reporting

Benefits

this position is eligible for an annual performance pay bonus
Alkermes offers a competitive benefits package
Additional details can be found on our careers website: www.alkermes.com/careers#working-here

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