Associate Director of Statistical Programming - Permanent Hybrid Role

ClinChoiceUnited States

Hybrid Full-time

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Experience Level

Senior Level Manager

Qualifications

The Associate Director of Programming will act as a strategic and technical leader within the Biometrics team. Responsibilities include overseeing clinical programming deliverables across various studies, managing both internal and external resources, and promoting the implementation of modern programming tools and standards. The ideal candidate will possess significant expertise in SAS and/or R, thorough knowledge of CDISC standards, and experience in supporting regulatory submissions.

About the job

ClinChoice is actively seeking an Associate Director of Statistical Programming for a permanent position in a hybrid work model. This role offers a unique chance to lead crucial statistical strategies within a vibrant and fast-paced environment.

This position is hybrid, preferably requiring candidates to travel to our client’s location in Waltham, MA.

We are looking for a seasoned Associate Director of Programming to spearhead programming initiatives, develop scalable processes, and guarantee the delivery of high-quality outputs for regulatory submissions.

About ClinChoice

ClinChoice is a leading global Contract Research Organization (CRO) dedicated to providing high-quality, innovative services for clinical research. Our unique blend of single-sponsor focus and global reach allows us to deliver exceptional value and support to our clients, fostering an environment where our employees can thrive.

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About the Role Zenas Bio is looking for a Director of Global Quality Assurance with expertise in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). This leader will guide the company’s quality assurance activities and maintain compliance with regulatory standards. Key Responsibilities Oversee global quality assurance processes related to GCP and GLP. Ensure all practices meet current regulatory requirements and industry standards. Location This position is based in Waltham, MA.

Apr 14, 2026

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Director of Clinical Quality Assurance

Oruka Therapeutics

Full-time|$213K/yr - $240K/yr|Remote|Waltham, Massachusetts, United States

About Us:At Oruka Therapeutics (Nasdaq: ORKA), we are pioneering innovative biologics aimed at transforming the treatment landscape for chronic skin disorders. Our mission is to empower individuals battling chronic skin conditions, such as plaque psoriasis, by providing them with the utmost freedom from their ailments, achieving significant disease clearance through infrequent dosing, potentially just once or twice yearly. Our proprietary collection of antibodies, meticulously crafted by Paragon Therapeutics, targets the fundamental mechanisms of plaque psoriasis and other dermatological and inflammatory conditions. To learn more, visit www.orukatx.com.As we expand our core team, we are on the lookout for exceptional talent across various functional areas—individuals who seek more than just employment, but rather a chance to be part of something transformative. We value passion for making a difference and contributions to fostering an engaged, inclusive, and positive workplace culture.Job Title: Director of Clinical Quality AssuranceLocation: Remote; candidates located in the Waltham, MA area are preferred.Role Overview:The Director of Clinical Quality Assurance will provide strategic leadership and oversight for Oruka's clinical development initiatives, focusing primarily on Good Clinical Practice (GCP) and associated quality systems that support clinical trials. This role will establish, enhance, and oversee clinical quality processes appropriate to each phase, ensuring comprehensive supervision of clinical trial execution and vendor performance while preparing for global health authority inspections, including FDA Bioresearch Monitoring (BIMO) inspections.This position will collaborate closely with Clinical Operations, Clinical Development, Biometrics, Pharmacovigilance, Regulatory Affairs, Medical Writing, and external service providers to ensure compliance with GCP, relevant global regulations, internal procedures, and protocol requirements throughout the clinical trial lifecycle. The Director of Clinical QA will proactively contribute quality insights, support continuous improvement initiatives, and help cultivate a quality-centric culture as the organization progresses with its pipeline.Key Responsibilities:Clinical Quality Oversight: Ensure compliance with GCP and applicable regulatory requirements for new and ongoing clinical studies.

Apr 9, 2026

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Associate Director/Director of Analytical Development and Validation - Tech Operations (Biologics)

Oruka Therapeutics

Full-time|$182K/yr - $240K/yr|Hybrid|Remote; Waltham, Massachusetts, United States

About Us:Oruka Therapeutics (Nasdaq: ORKA) is pioneering innovative biologic therapies aimed at transforming the treatment landscape for chronic skin conditions. Our mission is to empower individuals suffering from chronic skin diseases, such as plaque psoriasis, by providing unprecedented freedom from their ailments through treatments administered as infrequently as once or twice a year. We are advancing a proprietary portfolio of potentially best-in-class antibodies developed by Paragon Therapeutics, targeting the fundamental mechanisms of plaque psoriasis and other dermatological and inflammatory disorders. For more details, visit www.orukatx.comAs we fortify our core team, we are on the lookout for exceptional talent across various domains. We seek individuals who are not just looking for employment, but are eager to contribute to a larger purpose. If you are passionate about making a significant impact and are keen on fostering an engaged, inclusive, and positive workplace culture, we want to hear from you.Job Title: Associate Director/Director of Analytical Development and Validation - Tech Operations (Biologics)Location: Hybrid – Waltham, MA. Candidates are expected in the office 3 days a week. Remote considerations may apply.Role Overview:The Associate Director/Director of Analytical Development and Validation will provide scientific and strategic leadership for late-stage analytical activities that support the development, validation, and lifecycle management of biologic drug products, particularly monoclonal antibodies. This position will oversee method validation and comparability initiatives essential for BLA/MAA submissions, process modifications, and commercial readiness, collaborating closely with CMC, Quality, Regulatory Affairs, and external partners.The ideal candidate is a proactive leader with extensive experience in analytical method validation, device functional testing, and regulatory frameworks for late-stage biologics. You will guide teams through intricate technical and compliance milestones, making this a highly visible role within the CMC team. Join our expanding organization and play a crucial part in supporting multiple programs’ analytical activities, facilitating the release of supplies for clinical trials, and preparing for commercialization in the US, Canada, and EU.

Apr 10, 2026

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Associate Director of Sales Operations

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Full-time|On-site|Waltham

Deciphera Pharmaceuticals, Inc. is on the lookout for a seasoned Associate Director of Sales Operations to spearhead and enhance our field-facing operational strategies. This pivotal role will support the establishment of a high-performing Commercial field team, particularly focused on facilitating a successful brand launch. The successful candidate will ensure compliance, efficiency, and data-driven insights within field operations across our Hematology Franchise, playing a crucial role in ensuring operational readiness for product launches and ongoing excellence initiatives in the field.Key ResponsibilitiesFormulate and implement field operations strategies that align with both commercial and medical objectives.Manage field technology platforms including CRM systems, roster management, and reporting tools in collaboration with the IT department.Oversee territory design, roster management, and alignment processes to ensure compliance with coverage models.Coordinate onboarding operations with Training, HR, and Compliance teams.Direct the creation of field reports, dashboards, KPI tracking, and business insights.Ensure all field operations processes adhere to FDA, OIG, and corporate compliance standards.Lead continuous improvement initiatives aimed at enhancing scalability, efficiency, and quality.Collaborate effectively across functions including Sales, Marketing, Medical, Compliance, IT, HR, Legal, and Finance.

Feb 25, 2026

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Associate Director of Clinical Operations

Oruka Therapeutics

Full-time|$182K/yr - $208K/yr|Hybrid|Waltham, Massachusetts, United States

Oruka Therapeutics is developing biologics designed to change the treatment landscape for chronic skin conditions such as plaque psoriasis. The company focuses on long-lasting relief for patients, aiming for outcomes like disease clearance with infrequent dosing. Their pipeline includes proprietary antibodies created by Paragon Therapeutics, targeting the underlying causes of dermatologic and inflammatory diseases. More details about their work can be found at www.orukatx.com. Role overview The Associate Director of Clinical Operations will manage the setup and execution of clinical trials, supporting the Director of Clinical Operations within a specific therapeutic area. This position oversees multiple studies, combining strategic planning with day-to-day operational involvement to keep clinical programs on track and within budget. Responsibilities include handling operational details, anticipating challenges, and implementing solutions to ensure trial progress. The role requires someone who can move between leadership and hands-on work, maintaining a player/coach mindset throughout. What you will do Oversee all phases of clinical trial setup and execution across several studies Support the Director of Clinical Operations in a designated therapeutic area Balance strategic planning with direct, hands-on involvement in daily operations Identify and resolve operational challenges to maintain study timelines and budgets Requirements Demonstrated integrity and sound judgment in clinical operations Ability to shift between high-level oversight and direct involvement as needed Strong commitment to study goals and a collaborative approach Adaptability and resourcefulness in a biotech setting This hybrid role is based in Waltham, Massachusetts, with an expectation of three days onsite each week. The team values learning, growth, and a positive, inclusive culture.

Apr 22, 2026

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Senior Director of R&D Quality Assurance (GCP-GLP-GvP)

Crescent Biopharma

Full-time|On-site|Waltham, MA

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Feb 9, 2026

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Full-time|$140.8K/yr - $176K/yr|On-site|Waltham, MA

Zenas BioPharma is a pioneering biopharmaceutical company at the forefront of developing and commercializing transformative therapies for patients suffering from autoimmune diseases. Our strategic approach combines a seasoned leadership team with a rigorous process for acquiring and developing innovative product candidates globally. We are focused on delivering superior clinical benefits to patients affected by autoimmune disorders. We are advancing two late-stage flagship molecules: obexelimab and orelabrutinib. Obexelimab is our lead candidate, a bifunctional monoclonal antibody targeting CD19 and FcγRIIb, aimed at inhibiting the activity of pathogenic B cells without causing depletion. This innovative therapy offers a self-administered subcutaneous injection regimen, addressing chronic autoimmune diseases effectively. Orelabrutinib, on the other hand, is a highly selective oral small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor, designed to tackle compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). We also have promising earlier-stage programs, including a preclinical oral IL-17AA/AF inhibitor and a brain-penetrant TYK2 inhibitor.We are on the lookout for exceptional talent who share our dedication to improving patient outcomes and possess a proven track record in global product acquisition, development, and commercialization. Joining Zenas provides an opportunity to thrive in a dynamic learning environment where individual and organizational success is paramount as we aspire to become a global leader in immunology and autoimmune disease management. Our core values—Transparency, Relationships, Urgency, Excellence, and Innovation—drive us toward TRUE Innovation!Position Summary:As the Senior Manager of Global Quality Assurance for Technical Operations, you will report directly to the Director of Global Quality Assurance for Medical Devices and Combination Products. This strategic role encompasses hands-on quality oversight for late clinical-stage and commercial manufacturing activities at Zenas BioPharma’s Contract Manufacturing Organizations (CMOs). You will ensure the highest standards of GMP compliance across our global operations, facilitate regulatory submissions and inspections, and drive continuous improvement initiatives alongside internal teams and external manufacturing partners. Your responsibilities will include overseeing batch manufacturing and testing, process validation, and ensuring inspection readiness to maintain robust product quality throughout the development lifecycle.

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Mar 30, 2026

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Full-time|On-site|Waltham, MA

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Apr 21, 2026

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Associate Director of Statistical Programming - Permanent Hybrid Role

ClinChoice

Full-time|Hybrid|United States

Are you looking for an opportunity to work closely with a single sponsor while benefiting from the stability and growth opportunities provided by a global CRO? Join our team at ClinChoice, where we believe it's the best of both worlds. ClinChoice is actively seeking an Associate Director of Statistical Programming for a permanent position in a hybrid work model. This role offers a unique chance to lead crucial statistical strategies within a vibrant and fast-paced environment. This position is hybrid, preferably requiring candidates to travel to our client’s location in Waltham, MA. We are looking for a seasoned Associate Director of Programming to spearhead programming initiatives, develop scalable processes, and guarantee the delivery of high-quality outputs for regulatory submissions.

Feb 5, 2026

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