Senior Manager, Statistical Programming - Job ID: 1646

<p>Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.</p><p>Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.</p><p>Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.</p><p>Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.</p><p>The Senior Manager, Statistical Programming, will be expected to provide timely and strategic programming support to clinical study teams in alignment with project goals. This role combines hands-on programming responsibilities with leadership in study execution and tool development.</p><p>The successful candidate will serve as the <strong>Statistical Programming Lead</strong> for one or more clinical trials, taking responsibility for all programming deliverables from study start through regulatory submission. In addition, this person will <strong>support the development and maintenance of departmental programming tools</strong>, such as standard macros and specification templates of SDTM and ADaM used across clinical studies.</p><p>This position requires expertise in CDISC standards (SDTM, ADaM), strong communication and leadership skills, and a deep understanding of clinical trial data and analysis workflows.</p><p>&nbsp;</p><p>This position is based in Palo Alto, CA or may be remote.</p><p></p><p><strong>Key Responsibilities</strong></p><ul><li>Serve as the <strong>Statistical Programming Lead</strong> for clinical trials, overseeing all programming deliverables from study start to submission.</li></ul><ul> <li>Represent Statistical Programming in cross-functional study team meetings and contribute to project planning and timelines.</li> <li>Develop, validate, and maintain <strong>SDTM and ADaM datasets</strong>, following CDISC standards and study specifications.</li> <li>Generate or validate <strong>tables, listings, and figures (TLFs)</strong> for clinical study reports, ISS/ISE, and regulatory submissions.</li> <li>Support statisticians with planned and ad hoc analyses.</li> <li>Develop and maintain <strong>reusable macros, templates, and specification tools</strong> to support consistent and efficient programming practices across studies.</li> <li>Collaborate with cross-functional teams including Biostatistics, Data Management, and Medical Writing to ensure high-quality deliverables.</li> <li>Ensure programming activities meet project timelines and quality expectations, following internal SOPs and industry best practices.</li> </ul> <ul> <li>Bachelor’s degree in Statistics, Mathematics, Computer Science, or related field with at least <strong>10 years</strong> of programming experience in the pharmaceutical or biotech industry; or a Master’s degree with at least <strong>7 years</strong> of relevant experience.</li> <li>Proven experience as a <strong>lead programmer</strong> for clinical trials and complex technical projects.</li> <li> <strong>Excellent knowledge of CDISC standards</strong>, including SDTM and ADaM.</li> <li>Understanding of the <strong>clinical drug development process</strong> and regulatory requirements.</li> <li>Proficiency in SAS programming, including the ability to develop and validate <strong>reusable macros</strong>.</li> <li>Familiarity with other programming languages or tools (e.g., <strong>R</strong>, <strong>Python</strong>, <strong>Git</strong>, <strong>VB</strong>) is a plus.</li> <li>Experience contributing to <strong>departmental tools</strong> (e.g., macro libraries, specification templates, or automation tools) is preferred.</li> <li>Strong verbal and written communication skills, with the ability to collaborate effectively across functions.</li> <li>Self-motivated and detail-oriented, with the ability to manage multiple tasks and adapt to shifting priorities under tight deadlines.</li> </ul><p>Salary Range: $170-180K/year</p><p></p><p><strong>A note to recruiters:</strong></p><p><strong>We do not allow external search party solicitation.&nbsp; Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed.&nbsp; If this occurs your ownership of these candidates will not be acknowledged.</strong></p> <ul> <li>401(k) plan with company match </li> <li>Medical, dental, and vision plans </li> <li>Company-offered Life and Accidental Death &amp; Dismemberment (AD&amp;D) insurance </li> <li>Company-provided short and long-term disability benefits </li> <li>Unique offerings of Pet Insurance and Legal Insurance</li> <li>Employee Assistance Program</li> <li>Employee Discounts</li> <li>Professional Development</li> <li>Health Saving Account (HSA)</li> <li>Flexible Spending Accounts</li> <li>Various incentive compensation plans</li> <li>Accident, Critical Illness, and Hospital Indemnity Insurance&nbsp;&nbsp; </li> <li>Mental Health resources </li> <li>Paid leave benefits for new parents </li> </ul>