Associate Director, Statistical Programming

Alnylam Pharmaceuticals, Inc.; Cambridge, Northern (MA, KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

The Associate Director, Statistical Programming at Alnylam Pharmaceuticals, Inc. in Cambridge, MA, leads statistical programming activities for clinical trials, ensuring the quality and timely delivery of SAS-based deliverables in accordance with ICH guidelines and regulatory requirements.

The role requires SAS expertise and strong leadership of programming teams, with experience in CDISC standards (SDTM/ADaM) and Define-XML; knowledge of R is strongly preferred for data visualization and

Qualifications

• At least 10 years’ industry SAS programming experience or equivalent.
• Experience as a Programming manager (FTEs, FS Providers or vendors).
• Experience leading programming teams in support of clinical trials to report the results of clinical trials, integrate analyses across a program, or prepare data/analysis for regulatory submissions.
• Experience in constructing technical programming specifications and producing complex, validated SAS programs.
• Demonstrated experience in working with CDISC standards, including SDTM, and ADaM, and Define xml.
• Proficiency in understanding of statistical programming environments, processes, procedures, and roles.
• Excellent knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL with a demonstrated mastery of SAS/STAT procedures.
• Hands‑on experience with R programming for clinical trial data analysis, reporting, and regulatory submissions.
• Knowledge of R packages and frameworks commonly used in clinical development, Posit Workbench (RStudio Server), Posit Package Manager, and enterprise R environments.
• Experience developing SOPs, Standards or implement programming best practices.
• Experience overseeing vendors in the delivery of quality programming support.
• Excellent written and oral communication and organizational skills required.
• Bachelor’s Degree required, master’s degree preferred, in areas of computer science, statistics, mathematics or information sciences.
• Clear alignment with Alnylam Core Values: Commitment to People; Innovation and Discovery; Sense of Urgency; Open Culture; Passion for Excellence

Responsibilities

• Provides technical and/or operational leadership in the delivery of high quality and timely statistical programming for clinical studies, drug programs, and/or in support of NDA submissions.
• Works closely with Biostatistics to implement statistical analysis of clinical trial data, working closely on the development and validation of CDISC ADaM specifications and datasets, and TLFs for analyses to support regulatory, medical affairs, and market access needs.
• Works closely with Data Management on cross‑functional data review and the development and validation of CDISC SDTM specifications and datasets and define packages, may also support Drug Safety to support safety data review and reporting needs, and/or Clinical Pharmacology to support their dataset creation and analytic needs.
• Manages internal and vendor statistical programming support; Maintains strong collaboration and governance with preferred vendors.
• Writes SAS and R code that produces or validates tables, listings, figures and analysis datasets, in support of clinical studies or complex integrated analyses for submission.
• Performs, plans and coordinates project work to ensure timely, quality delivery across multiple projects, or across a drug program.
• Writes specifications to describe programming needs, including development and maintenance of complex / ADaM specifications and reviewer guides.
• May lead the creation and validation of global macros or systems that streamline repetitive operations to increase programming efficiency.
• Provides input into, or leads general standardization efforts (e.g., CRFs, query checks, standard statistical programs, data presentations).
• Leads efforts to develop programming processes consistent with industry best practices.
• Reviews and provides expert input to DMP, eCRF specs, and other clinical data management documents; Reviews and provides expert input to statistical analysis plans and other related documents.
• Partners with or oversees CROs or Programming vendors to perform any of the above tasks.

Skills

SAS programming

Leadership

CDISC SDTM/ADaM

R programming

Regulatory submissions

Vendor management

SAS/STAT

SAS/GRAPH

Education

Bachelor’s Degree in related field

Master’s Degree preferred

Tools

SAS

R

Posit Workbench (RStudio Server)

CDISC Define-XML

Job description

Associate Director, Statistical Programming

Cambridge, MA

The Associate Director, Statistical Programming is responsible for statistical programming activities in support of clinical trials including technical and project leadership overseeing the quality and timely delivery of all statistical programming deliverables for studies or for a submission. He/she ensures the team develops, maintains, validates and runs quality SAS programs that access, visualize, analyze, and report clinical trial data in accordance with statistical analysis plans, ICH guidelines, and applicable regulatory requirements. While SAS expertise is required, experience with R programming, particularly data visualization and exploratory analysis is strongly preferred.

Summary of Key Responsibilities

• Provides technical and/or operational leadership in the delivery of high quality and timely statistical programming for clinical studies, drug programs, and/or in support of NDA submissions.
• Works closely with Biostatistics to implement statistical analysis of clinical trial data, working closely on the development and validation of CDISC ADaM specifications and datasets, and TLFs for analyses to support regulatory, medical affairs, and market access needs.
• Works closely with Data Management on cross‑functional data review and the development and validation of CDISC SDTM specifications and datasets and define packages, may also support Drug Safety to support safety data review and reporting needs, and/or Clinical Pharmacology to support their dataset creation and analytic needs.
• Manages internal and vendor statistical programming support; Maintains strong collaboration and governance with preferred vendors.
• Writes SAS and R code that produces or validates tables, listings, figures and analysis datasets, in support of clinical studies or complex integrated analyses for submission.
• Performs, plans and coordinates project work to ensure timely, quality delivery across multiple projects, or across a drug program.
• Writes specifications to describe programming needs, including development and maintenance of complex / ADaM specifications and reviewer guides.
• May lead the creation and validation of global macros or systems that streamline repetitive operations to increase programming efficiency.
• Provides input into, or leads general standardization efforts (e.g., CRFs, query checks, standard statistical programs, data presentations).
• Leads efforts to develop programming processes consistent with industry best practices.
• Reviews and provides expert input to DMP, eCRF specs, and other clinical data management documents; Reviews and provides expert input to statistical analysis plans and other related documents.
• Partners with or oversees CROs or Programming vendors to perform any of the above tasks.

Qualifications

• At least 10years’ industry (Pharmaceutical, Biotech, CRO) SAS programming experience or equivalent;
• Experience as a Programming manager (FTEs, Functional Service Providers or vendors);
• Experience leading programming teams in support of clinical trials to report the results of clinical trials, integrate analyses across a program, or prepare data/analysis for electronic NDA or BLA submission;
• Experience in constructing technical programming specifications and producing complex, validated SAS programs;
• Demonstrated experience in working with CDISC standards, including SDTM, and ADaM, and Define xml;
• Proficiency in understanding of statistical programming environments, processes, procedures, and roles;
• Excellent knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL with a demonstrated mastery of SAS/STAT procedures;
• Hands‑on experience with R programming for clinical trial data analysis, reporting, and regulatory submissions.
• Knowledge of R packages and frameworks commonly used in clinical development, Posit Workbench (RStudio Server), Posit Package Manager, and enterprise R environments.
• Experience developing SOPs, Standards or implement programming best practices;
• Experience overseeing vendors in the delivery of quality programming support;
• Excellent written and oral communication and organizational skills required;
• Bachelor’s Degree required, master’s degree Preferred, in areas of computer science, statistics, mathematics or information sciences.
• Clear alignment with Alnylam Core Values:
• Commitment to People
• Innovation and Discovery
• Sense of Urgency
• Open Culture
• Passion for Excellence

About Alnylam

We are the leader in RNAi therapeutics– a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what’s possible. Our deep pipeline, late‑stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E‑Verify Employer.

The pay range below reflects the full‑time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short‑term incentive award (e.g., bonus or sales incentive) and an annual long‑term incentive award (e.g., equity).

Alnylam’s robust Total Rewards package is designed to support your overall health and well‑being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company‑wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well‑being reflects our belief that caring for our people fuels the impact we create together.

US - Voluntary Self-Identification of Veteran & Disability Status

Why are you being asked to complete this form?

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.

Protected veterans may have additional rights under USERRA—the Uniformed Services Employment and Reemployment Rights Act. In particular, if you were absent from employment in order to perform service in the uniformed service, you may be entitled to be reemployed by your employer in the position you would have obtained with reasonable certainty if not for the absence due to service. For more information, call the U.S. Department of Labor's Veterans Employment and Training Service (VETS), toll‑free, at 1-866-4-USA-DOL.

If you believe you belong to any of the categories of protected veterans listed above, please indicate by checking the appropriate box below. As a Government contractor subject to VEVRAA, we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA.

Submission of this information is voluntary and refusal to provide it will not subject you to any adverse treatment. The information provided will be used only in ways that are not inconsistent with the Vietnam Era Veterans' Readjustment Assistance Act of 1974, as amended.

Voluntary Self‑Identification of Disability (Form CC‑305 / OMB Control Number 1250‑0005 / Expires: 04/30/2026)

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 I know if I have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

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