Back to jobs
New

Director / Senior Director of Statistical Programming

Waltham, MA

Director / Senior Director of Statistical Programming

Skyhawk Therapeutics is seeking an experienced and strategic Director / Senior Director of Statistical Programming to lead and scale the statistical programming function. This role is responsible for setting the strategic direction of programming operations, overseeing CRO partnerships, and driving high-quality delivery across the clinical portfolio. Reporting to the Executive Director of Biostatistics, this role serves as a key technical and operational leader, shaping programming standards, cross-functional collaboration, and the development of internal capabilities.

Responsibilities (including, but not limited to):

  • Define and evolve the statistical programming outsourcing strategy; provide executive oversight of all programming activities outsourced to CRO 
  • Lead and partner with cross-functional teams (Biostatistics, Clinical Operations, Regulatory, Data Management) to direct internal exploratory analyses and inform strategic decisions  
  • Lead the statistical programming portfolio across multiple programs; define and implement department-wide programming strategies and standards 
  • Champion the development, implementation, and governance of programming standards and specifications in accordance with regulatory guidelines; ensure consistency across the clinical portfolio   
  • Provide strategic oversight of CRO programming delivery, including analysis datasets, listings, tables, and figures for clinical trials; ensure adherence to specifications, quality standards, and milestones; contribute hands-on programming expertise as the business requires for clinical trials with high quality and within milestones 
  • Provide senior-level input into SAPs, CRFs, and data structures; ensure all documents and specifications maintain cross-functional consistency and compliance with regulatory structures 
  • Establish and oversee processes for documentation, record-keeping, and archiving of all project analyses and associated documentation; build scalable processes to support growing clinical programs 
  • Recruit, mentor, and develop statistical programming talent; build a high-performing team culture centered on scientific rigor, innovation, and continuous improvement 
  • Serve as the internal expert and point of escalation for complex programming issues; collaborate with Regulatory Affairs on agency submissions and responses 
  • Evaluate, select, and manage programming tools, technologies, and vendors to support an efficient and scalable programming infrastructure 

Requirements, Education, Experience & Skills:

  • 10+ years of statistical programming experience in the CRO or biopharmaceutical industry
  • Excellent SAS programming and analytical skills using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS 
  • Strong CDISC SDTM and ADaM experience 
  • Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials 
  • Experiece supporting regulatory submissions (e.g., NDA. BLA, or MAA)
  • Strong initiative and a collaborative team player; ability to work with a variety of both internal and external stakeholders 
  • Excellent attention to detail and problem-solving skills with a demonstrated ability to identify data and programming gaps and drive them to resolution 
  • Demonstrated experience managing CRO relationships and leading vendor oversight programs at a strategic level 
  • Excellent written and oral communication skills; ability to effectively communicate complex technical concepts to senior leadership and non-technical stakeholders 
  • Proven ability to work strategically and independently; comfortable operating in a fast-paced, dynamic environment with competing priorities 
  • Experience with people management, team development, or mentoring statistical programming staff 

Skyhawk Therapeutics is committed to pay transparency and equitable compensation practices. The base salary range for the Director / Senior Director of Statistical Programming role is $225,000-325,000 annually. This range reflects the minimum and maximum target for such position. Skyhawk Therapeutics will assess the appropriate level for a qualified candidate based on job-related skills, professional experience, and relevant education or training.

About Skyhawk

Skyhawk is committed to discovering, developing and commercializing small molecule therapeutics that modify RNA expression. We use our novel SkySTAR® platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed toward targets for some of the world’s most intractable diseases including neurological conditions, cancer, and traditionally “undruggable” targets.

Create a Job Alert

Interested in building your career at Skyhawk Therapeutics? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Education

Select...
Select...
Select...
Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Skyhawk Therapeutics’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 07/31/2029

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.