Senior Manager, Statistical Programming

<p>Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases. </p><p></p><p><b>Summary:</b></p>Independent Trial Programmer for major therapeutic area, responsible for 2-3 trials in the same therapeutic area. Ability to offer consulting, training, and support to users on applications developed by internal systems group. Independent Statistical Reporting representative on major Apellis initiatives.<p></p><p><b>Roles and Responsibilities:</b></p><ul><li><span>Act<span> </span>as<span> </span>an<span> </span>independent<span> </span>therapeutic<span> </span>area<span> </span>trial<span> </span>Programmer<span> </span>for<span> </span>assigned<span> </span>trials,<span> </span>take<span> </span>a<span> </span>programming leadership role on the Biometrics project team.</span></li><li><span>Maintain<span> </span>efficient<span> </span>interfaces<span> </span>with<span> </span>internal<span> </span>and<span> </span>external<span> </span>customers<span> </span>Trial<span> </span>Data<span> </span>Manager<span> </span>and<span> </span>the<span> </span>Trial Statistician for high level strategic advice.</span></li><li><span>Manage<span> </span>complex<span> </span>trials<span> </span>and<span> </span>aid<span> </span>in<span> </span>therapeutic<span> </span>area<span> </span>programming<span> </span><span>strategies.</span></span></li><li><span>Develop<span> </span>and<span> </span>comply<span> </span>with<span> </span>project<span> </span>/<span> </span>study<span> </span>standards<span> </span>and<span> </span>specifications<span> </span>following<span> </span>internal<span> </span>and<span> </span>regulatory guidelines and Apellis SOPs and values.</span></li><li><span>Develop<span> </span>resource<span> </span>plans<span> </span>as<span> </span>required<span> </span>to<span> </span>support<span> </span>headcount<span> </span>justifications,<span> </span>resource<span> </span>forecasting<span> </span>and <span>allocations.</span></span></li><li><span>Participate<span> </span>and<span> </span>support<span> </span>SOP,<span> </span>process,<span> </span>and<span> </span>work<span> </span>aid<span> </span><span>development.</span></span></li><li><span>Oversee<span> </span>programming<span> </span>style,<span> </span>quality<span> </span>of<span> </span>Biometrics<span> </span>contributions<span> </span>and<span> </span>compliance<span> </span>with <span>timelines.</span></span></li><li><span>To program as required and oversee delivery, according to specifications, analysis datasets, pooled datasets,<span> </span>listings,<span> </span>tables,<span> </span>and<span> </span>figures<span> </span>for<span> </span>phase<span> </span>I-IV<span> </span>clinical<span> </span>trials<span> </span>and<span> </span>for<span> </span>ISS<span> </span>and<span> </span>ISE<span> </span>with<span> </span>high<span> </span>quality<span> </span>and within milestones.</span></li><li><span>Ensure<span> </span>that<span> </span>documents<span> </span>and<span> </span>specifications<span> </span>are<span> </span>consistent<span> </span>and<span> </span>comply<span> </span>with<span> </span>company<span> </span>standards<span> </span>by<span> </span>providing input into CRF and data structures.</span></li><li><span>Induct,<span> </span>supervise,<span> </span>and<span> </span>train<span> </span>programmers<span> </span>on<span> </span>programming<span> </span>skills,<span> </span>trial<span> </span>and<span> </span>project<span> </span>level<span> </span>activities,<span> </span>and internal processes.</span></li><li><span>Support<span> </span>quality<span> </span>control<span> </span>and<span> </span>quality<span> </span>audit<span> </span>of<span> </span><span>deliverables.</span></span></li><li><span>Maintain<span> </span>records<span> </span>for<span> </span>all<span> </span>assigned<span> </span>projects<span> </span>and<span> </span>archiving<span> </span>of<span> </span>trial<span> </span>/<span> </span>project<span> </span>analysis<span> </span>and<span> </span>associated <span>documentation.</span></span></li><li><span>Follow<span> </span>outsourcing<span> </span>strategy<span> </span>as<span> </span>defined<span> </span>within<span> </span>Biometrics<span> </span>and<span> </span>supervise<span> </span>all<span> </span>outsourced activities outsourced to CRO.</span></li><li><span>Provide<span> </span>input<span> </span>on<span> </span>process<span> </span>improvement<span> </span>initiatives<span> </span>and<span> </span>participate<span> </span>in<span> </span>non-clinical<span> </span>project<span> </span>activities<span> </span>with support from management.</span></li><li><span>Operationally<span> </span>manage<span> </span>Statistical<span> </span>programmers<span> </span>as<span> </span><span>needed.</span></span></li></ul><p></p><p>Education &amp; Experience:</p><ul><li>BS/BA, MS Preferable</li><li>8-10 years in senior programming /statistical role within pharmaceutical industry strongly preferred</li></ul><p></p><p>Knowledge, Skills &amp; Abilities:</p><ul><li>Strong hands-on SAS programing skills for clinical trial reporting.</li><li>Excellent SAS programming and analytical skills using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS.</li><li>Strong CDISC SDTM and ADaM experience.</li><li>Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials.</li><li>Strong interpersonal, organizational, and multi-tasking skills. Excellent attention to detail and problem-solving skills.</li><li>Good trial management skills, CRO oversight skills, professional attitude, self-improvement mentality with positive attitude.</li><li>Good written and oral presentation skills and ability to communicate effectively.</li><li>Ability to think creatively and independently, and to form sound opinions and make sensible decisions in a dynamic environment.</li><li>Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA. NDA/BLA or other regulatory filing experience, including ISS or ISE experience. Thorough understanding of ICH Guidelines and relevant regulatory requirements.</li></ul><p></p><p><b>Travel Requirements:</b></p><p></p><p><b>Education:</b></p><p></p><p><b>Pay Information:</b></p>Base salary for this role will consider multiple factors, including but not limited to, candidate qualifications, relevant expertise, specialized skills, and industry experience in complement-targeted therapies. The targeted base salary range for this position is $164,200-$246,300. This range represents the base salary only and reflects Apellis' commitment to competitive compensation within the biopharmaceutical industry. The final salary offered may vary based on individual qualifications, business needs, and current market conditions.<p></p><p><b>Work Arrangement:</b></p><p></p><p><b><span style="font-size:14px">Benefits and Perks:</span></b><span style="font-size:14px"><br /><br />Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more! Visit </span><a target="_blank" href="https://apellis.com/careers/benefits/"><span style="color:#0000ff"><u><span style="font-size:14px">https://apellis.com/careers/benefits/</span></u></span></a><span style="font-size:14px"> to learn more.<br /><br /></span><b><span style="font-size:14px">Company Background:</span></b><span style="font-size:14px"><br /><br />Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company leading the way in complement science to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two C3-targeting medicines approved to treat four serious diseases. Breakthroughs for patients include the first-ever therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients 12 and older with C3G or primary IC-MPGN, two severe, rare kidney diseases. We believe we have only begun to unlock the potential of targeting C3 across many serious diseases.</span></p><p><span style="font-size:14px"> </span></p><p><span style="font-size:14px">For more information, please visit </span><a target="_blank" href="https://apellis.com/"><span style="color:#0000ff"><u><span style="font-size:14px">http://apellis.com</span></u></span></a><span style="font-size:14px"> or follow us on </span><a target="_blank" href="https://www.linkedin.com/company/apellis"><span style="color:#0000ff"><u><span style="font-size:14px">LinkedIn</span></u></span></a><span style="font-size:14px"> and </span><a target="_blank" href="https://x.com/apellispharma?lang&#61;en"><span style="color:#0000ff"><u><span style="font-size:14px">X</span></u></span></a><span style="font-size:14px">.</span></p><p><span style="font-size:14px"><br /></span><b><span style="font-size:14px">EEO Statement:</span></b><span style="font-size:14px"><br /><br />Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.<br /></span><b><span style="font-size:14px"><br /></span></b><span style="font-size:14px">For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.  <br /><br /></span><b><span style="font-size:14px">Other Duties:</span></b><span style="font-size:14px"><br /><br />Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.</span><br /> </p>