Manager/Senior Manager of Statistical Programming

About Us

The company (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. The company’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. The company is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon the company and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit [link for members]

As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.  Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.

Job Title: Manager/Sr Manager of Statistical Programming

Location: Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.

Role Overview

The company is seeking an experienced Manager/Sr Manager of Statistical Programming to lead programming efforts across multiple clinical studies. This role will be instrumental in ensuring high-quality, timely, and compliant statistical deliverables in support of the company clinical trials. The ideal candidate will bring deep technical expertise in SAS programming, CDISC standards, and regulatory submission readiness, along with strong leadership and vendor oversight capabilities.

Key Responsibilities

• Lead statistical programming activities for multiple clinical trials within a program or a complete development program

• Accountable for timely and quality development and validation of all statistical programming components on assigned program(s). Responsible for audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results

• Serve as the lead programmer to produce and/or validate tables, listings, figures, and analysis datasets for regulatory requests, publication needs, and ad-hoc analyses; write specifications for programming requirements

• Oversee CRO SAS programming by providing ongoing review of activities and progress to ensure projects are delivered by the CROs on time with suitable quality

• Work closely with Data Management and Biostatistics teams to ensure the accuracy of final databases, analyses, and reports. Oversee study-level programming deliverable timelines in collaboration with the study lead biostatistician and cross-functional teams

• Collaborate with biostatisticians and clinical development colleagues to develop/review TFL shells, SDTM, and ADaM specifications

• Identify issues and develop global tools, such as macros or graphical user interface applications, to enhance the efficiency and capacity of the statistical programming group

• Maintain up-to-date advanced knowledge of SAS software as well as industry requirements (e.g. CDISC, eCTD, Define.xml), attend functional meetings and training

• Represent statistical programming at program-level, in audits/inspections and Health Authority (HA) meetings

• Offer expert technical and professional recommendations, thought leadership for the statistical programming function at the program level

• Adhere to FDA regulations regarding training records, guidelines, and SOPs. Adhere to company SOPs/WIs and department guidelines

Qualifications

• BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree and 5+ years in a programming or statistical role

• At least 2+ years of experience as a Lead/Program/Project Programmer for one or more programs, including the coordination of large teams of internal and/or external programmers

• Demonstrated leadership, collaboration, and organizational skills with the ability to successfully manage and oversee multiple trials simultaneously, ensuring deadlines are met

• In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP)

• Advanced knowledge of industry standards, including CDISC standards, and a solid understanding of the development and use of standard programs

• SAS programming skills - procedures and options commonly used in clinical trials. reporting, including Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH, validation/QC, experience generating listings, tables, figures

• Experience with R programming a plus

• Must be able to program defensively, check results, and consistently produce accurate outputs

• Knowledge of regulatory guidelines (FDA, EMA, ICH) relevant to clinical trials, statistics, and data handling, along with advanced knowledge of submission requirements and standards

• Experience in contributing to the review of statistical analysis plans and developing technical programming specifications

• Experience with outsourcing programming activities and overseeing services provided by CROs and contractors

• NDA submission experience a plus

• Excellent interpersonal skills with a proven ability to operate effectively in a global environment, influencing and communicating across functions and with external stakeholders

• The ability to thrive in various situations, enthusiastically embracing organizational changes and evolving job demands

• Skills planning and managing multiple responsibilities concurrently, while maintaining high standards of quality and meeting deadlines under pressure

Compensation

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.

• The anticipated salary range for candidates, who will work remotely or in Waltham, MA, is $146,000 to $161,000 for Manager and for Sr Manager $161,000-$187,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. The company is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

Salary Range for the Role

$146,000 — $187,000 USD

What We Offer

• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.

• Competitive salary and benefits package.

• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.

• Opportunities for professional growth and development.